NDC 0113-0108 Good Sense Complete Lice Treatment Kit

Piperonyl Butoxide, Pyrethrum Extract

NDC Product Code 0113-0108

NDC CODE: 0113-0108

Proprietary Name: Good Sense Complete Lice Treatment Kit What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Piperonyl Butoxide, Pyrethrum Extract What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

NDC Code Structure

  • 0113 - L. Perrigo Company
    • 0113-0108 - Good Sense Complete Lice Treatment Kit

NDC 0113-0108-62

Package Description: 1 KIT in 1 CARTON * 59 mL in 1 BOTTLE, PUMP * 118 mL in 1 BOTTLE

NDC Product Information

Good Sense Complete Lice Treatment Kit with NDC 0113-0108 is a a human over the counter drug product labeled by L. Perrigo Company. The generic name of Good Sense Complete Lice Treatment Kit is piperonyl butoxide, pyrethrum extract. The product's dosage form is kit and is administered via form.

Labeler Name: L. Perrigo Company

Dosage Form: Kit - A packaged collection of related material.

Product Type: Human Otc Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • BENZYL ALCOHOL (UNII: LKG8494WBH)
  • C13-14 ISOPARAFFIN (UNII: E4F12ROE70)
  • WATER (UNII: 059QF0KO0R)
  • XANTHAN GUM (UNII: TTV12P4NEE)

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: L. Perrigo Company
Labeler Code: 0113
FDA Application Number: part358G What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 11-20-2018 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2020 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Good Sense Complete Lice Treatment Kit Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Active Ingredients

Piperonyl butoxide 4%Pyrethrum extract (equivalent to 0.33% pyrethrins)

Purpose

Lice treatment

Uses

Treats head, pubic (crab), and body lice

Warnings

For external use only

Do Not Use

  • •near eyes •inside nose, mouth, or vagina •on lice in eyebrows or eyelashes. See a doctor if lice are present in these areas.

Ask A Doctor Before Use If You Are

Allergic to ragweed. May cause breathing difficulty or an asthmatic attack.

When Using This Product

  • •keep eyes tightly closed and protect eyes with a washcloth or towel •if product gets in eyes, flush with water right away •scalp itching or redness may occur

Stop Use And Ask A Doctor If

  • •breathing difficulty occurs •eye irritation occurs •skin or scalp irritation continues or infection occurs

Keep Out Of Reach Of Children.

If swallowed, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Directions

  • •Important: Read warnings before use Adults and children 2 years and over:Inspect •check each household member with a magnifying glass in bright light for lice/nits (eggs) •look for tiny nits near scalp, beginning at back of neck and behind ears •examine small sections of hair at a time •unlike dandruff which moves when touched, nits stick to the hair •if either lice or nits are found, treat with this productTreat •shake well before using •apply thoroughly to DRY HAIR or other affected area. For head lice, first apply behind ears and to back of neck. •allow product to remain for 10 minutes, but no longer •use warm water to form a lather, shampoo, then thoroughly rinse •for head lice, towel dry hair and comb out tanglesRemove lice and their eggs (nits) •use a fine-tooth or special lice/nit comb. Remove any remaining nits by hand (using a throw-away glove). •hair should remain slightly damp while removing nits •if hair dries during combing, dampen slightly with water •for head lice, part hair into sections. Do one section at a time starting on top of head. Longer hair may take 1 to 2 hours. •lift a 1- to 2-inch wide strand of hair. Place comb as close to scalp as possible and comb with a firm, even motion away from scalp. •pin back each strand of hair after combing •clean comb often. Wipe nits away with tissue and discard in a plastic bag. Seal bag and discard to prevent lice from coming back. •after combing, thoroughly recheck for lice/nits. Repeat combing if necessary. •check daily for any lice/nits that you missed •a second treatment must be done in 7 to 10 days to kill any newly hatched lice •if infestation continues, see a doctor for other treatmentsChildren under 2 years: ask a doctor

Other Information

  • •store at 20-25°C (68-77°F) •avoid excessive heat •keep carton for important product information •see Consumer Information Insert for additional information

Inactive Ingredients

Benzyl alcohol, C13-C14 isoparaffin, fragrance, polyoxyethylene (1,1,3,3-tetramethyl butyl) phenyl ether, purified water, xanthan gum

Consumer Information

  • 3-STEP PROCESS FOR LICE TREATMENTSee carton for complete product information.Step 1 ● TreatApply Lice Killing ShampooSee Usage Guidelines to estimate how much product you will need.NOTE: •Shake well before using. •Use towels to protect child's eyes from treatment and prevent clothes from getting wet. •Apply Lice Killing Shampoo thoroughly to DRY HAIR or other affected area. •Wetting the hair dilutes the treatment making it less effective. •Also, lice can hold their breath when immersed in water making it difficult for the active ingredient to penetrate the lice. •For head lice, thoroughly massage shampoo into scalp, behind the ears and to the back of the neck. Lice can crawl up and down the shaft of the hair very quickly so it is important to apply the treatment from the roots to the ends of the hair. •Allow product to remain on the hair (or other affected area) for 10 minutes, but no longer. •Add warm water and massage to form a lather. •Rinse thoroughly. •For head lice, towel dry hair and comb out tangles. •Proceed to Step 2. •A second treatment must be done in 7 to 10 days to kill any newly hatched lice.Usage GuidelinesHair LengthShort (ear length or shorter)Medium (shoulder length)Long (past shoulder length)Approximate Amount for 1 Adult/Child First Application: 1 oz – 2 ozFirst Application: 2 oz – 3 ozFirst Application:3 oz – 4 ozSecond Application:1 oz – 2 ozSecond Application:2 oz – 3 ozSecond Application:3 oz – 4 ozTotal:2 oz – 4 ozTotal:4 oz – 6 ozTotal:6 oz – 8 oz Step 2 • RemoveComb out lice and eggs with lice comb or other fine-tooth comb and Lice & Egg Comb-Out SprayThis product should be used AFTER Lice Killing Shampoo (Step 1). Combing is an important step to remove eggs.NOTE: •A fine-toothed comb or the special lice/nit removing comb (included) must be used to remove lice, eggs, and nits from hair. •Before starting have on hand:-extra towels-bobby pins or hair clips-facial tissues or paper towels-regular comb for parting and detangling hair-throw-away gloves •Find a distraction for your child (e.g. books, TV, game). •Comb out damp hair with a regular wide-tooth comb to take out snarls and tangles.Apply a small amount of Lice & Egg Comb-Out Spray and use a wide-tooth comb to remove any tangles.Lift a 1-2" section of hair. Start as close to scalp as possible, slowly comb section all the way to ends of hair with lice comb, using additional Lice & Egg Comb-Out Spray to remove tangles as needed. Use a tissue or paper towel to wipe any lice or eggs off comb.Pin back this section of hair. Continue to comb out one 1-2” section at a time until entire head has been combed and pinned.Remove pins and rinse thoroughly with warm water. You may use your regular shampoo now if desired. Combs should be disinfected for reuse by soaking in hot water (above 130°F) for 10 minutes. Step 3 • ControlTreat the home with Home Lice, Bedbug & Dust Mite SprayUse Home Lice, Bedbug & Dust Mite Spray to kill lice and their eggs on mattresses, furniture, car interiors and other non-washable items.Not for use on humans.Additional Tips for Success •Be sure to complete all three steps in the Lice Treatment process. This includes a second shampooing between 7-10 days after the initial treatment, but no sooner. If any eggs were not initially combed out, lice may hatch and can be killed with the second treatment. Newly hatched lice are not mature enough to lay new eggs. •Carefully inspect infested family members daily for at least 2 weeks after the second shampooing. If you see eggs or nits, consult your doctor. •Teach children not to share personal items, such as hats, combs and brushes and to avoid prolonged contact with a person who has lice.Did You Know?HEAD LICE •Lay small white eggs (nits) on hair shaft close to scalp. •Nits are most easily found on back of neck or behind ears. •Disinfect hats, hair ribbons, scarves, coats, towels, and bed linens by machine washing in hot water (above 54°C (130°F)), then using hottest dryer cycle for at least 20 minutes. •Items that cannot be washed (bedspreads, blankets, pillows, stuffed toys, etc.) should be dry-cleaned or sealed in a plastic bag for 4 weeks, then removed outdoors and shaken out very hard before using again. •Items that cannot be washed, dry-cleaned, or stored may be sprayed with a product designed for this purpose. •Soak all combs and brushes in hot water (above 54°C (130°F)) for at least 10 minutes. •Vacuum all carpets, mattresses, upholstered furniture, and car seats that may have been used by affected people.PUBIC (CRAB) LICE •May be transmitted by sexual contact. Sexual partners should be treated simultaneously to avoid reinfestation. •Lice are very small and look like brown or grey dots on skin. •Usually cause intense itching and lay small white eggs (nits) on the hair shaft generally close to the skin surface. •May be present on the short hairs of groin, thighs, trunk, and underarms, and occasionally on the beard and mustache. •Disinfect underwear by machine washing in hot water (above 54°C (130°F)), then using hottest dryer cycle for at least 20 minutes.BODY LICE •Body lice and their eggs (nits) are generally found in the seams of clothing particularly in waistline and armpit area. •Body lice feed on skin then return to clothing to lay their eggs. •Disinfect clothing by machine washing in hot water (above 54°C (130°F)), then using hottest dryer cycle for at least 20 minutes. •Do not seal clothing in a plastic bag because nits can remain dormant for up to 30 days.Save this insert for future referenceDistributed ByPerrigo®Allegan, MI 49010: 6Y600 00 J1Keep carton for important product information.Lice Killing ShampooDrug FactsActive ingredientsPiperonyl butoxide 4%Pyrethrum extract (equivalent to 0.33% pyrethrins)PurposeLice treatmentUsestreats head, pubic (crab), and body liceWarningsFor external use onlyDo not use •near eyes •inside nose, mouth, or vagina •on lice in eyebrows or eyelashes. See a doctor if lice are present in these areas.Ask a doctor before use if you are allergic to ragweed. May cause breathing difficulty or an asthmatic attack.When using this product •keep eyes tightly closed and protect eyes with a washcloth or towel •if product gets in eyes, flush with water right away •scalp itching or redness may occurStop use and ask a doctor if •breathing difficulty occurs •eye irritation occurs •skin or scalp irritation continues or infection occursKeep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away (1-800-222-1222).Directions •Important: Read warnings before use Adults and children 2 years and over: Inspect •check each household member with a magnifying glass in bright light for lice/nits (eggs) •look for tiny nits near scalp, beginning at back of neck and behind ears •examine small sections of hair at a time •unlike dandruff which moves when touched, nits stick to the hair •if either lice or nits are found, treat with this product Treat •shake well before using •apply thoroughly to DRY HAIR or other affected area. For head lice, first apply behind ears and to back of neck. •allow product to remain for 10 minutes, but no longer •use warm water to form a lather, shampoo, then thoroughly rinse •for head lice, towel dry hair and comb out tangles Remove lice and their eggs (nits) •use a fine-tooth or special lice/nit comb. Remove any remaining nits by hand (using a throw- away glove). •hair should remain slightly damp while removing nits •if hair dries during combing, dampen slightly with water •for head lice, part hair into sections. Do one section at a time starting on top of head. Longer hair may take 1 to 2 hours. •lift a 1- to 2-inch wide strand of hair. Place comb as close to scalp as possible and comb with a firm, even motion away from scalp. •pin back each strand of hair after combing •clean comb often. Wipe nits away with tissue and discard in a plastic bag. Seal bag and discard to prevent lice from coming back. •after combing, thoroughly recheck for lice/nits. Repeat combing if necessary. •check daily for any lice/nits that you missed •a second treatment must be done in 7 to 10 days to kill any newly hatched lice •if infestation continues, see a doctor for other treatmentsChildren under 2 years: ask a doctorOther information •store at 20-25°C (68-77°F). Avoid excessive heat.Inactive ingredients benzyl alcohol, C13-C14 isoparaffin, fragrance, polyoxyethylene (1,1,3,3-tetramethyl butyl) phenyl ether, purified water, xanthan gumQuestions? 800-719-9260Lice & Egg Comb-Out Spray Product InformationUse detangles hair in order to make lice and egg comb-out easierWarnings For external use only. Keep out of reach of children. Avoid contact with eyes.Directions for use •use AFTER shampooing with a lice killing shampoo •towel dry hair. Apply a small amount of this product and use a wide-toothed comb to remove any tangles. •comb out the dead lice, eggs and nits, one small section at a time, with the enclosed lice comb. This step is very important. •use additional product to remove tangles, if needed, during the comb-out process •after you have combed entire head, rinse hair thoroughly with warm water. Disinfect combs with hot water (130°F).Ingredients purified water, polysorbate 20, glycerin, propylene glycol, phenoxyethanol, amodimethicone, fragrance, DL-panthenol, trideceth-12, cetrimonium chloride, methylchloroisothiazolinone, methylisothiazolinoneHome Lice, Bedbug & Dust Mite SprayNot for use on humans.ACTIVE INGREDIENT:†Permethrin……………………………………………………………………………………….0.50%††OTHER INGREDIENTS:……………………………………………………………………99.50%  100.00% †Cis/trans ratio: Max. 55% (+/-) cis and Min. 45% (+/-) trans. ††Contains petroleum distillate.FIRST AIDIf on skin or clothing: •Take off contaminated clothing. •Rinse skin immediately with plenty of water for 15-20 minutes. •Call a poison control center or doctor for treatment advice.If in eyes: •Hold eye open and rinse slowly and gently with water for 15-20 minutes. •Remove contact lenses, if present, after the first 5 minutes, then continue rinsing eye. •Call a poison control center or doctor for treatment advice.If swallowed: •Immediately call a poison control center or doctor. •Do not induce vomiting unless told to do so by a poison control center or doctor. •Do not give any liquid to the person. •Do not give anything by mouth to an unconscious person.If inhaled: •Move person to fresh air. •If person is not breathing, call 911 or an ambulance, then give artificial respiration, preferably by mouth-to-mouth, if possible.HOT LINE NUMBERHave the product container or label with you when calling a poison control center or doctor, or going for treatment. For additional information on this product (including health concerns, medical emergencies or pesticide incidents), you may call 1-800-222-1222.NOTE TO PHYSICIANContains petroleum distillate – vomiting may cause aspiration pneumonia.PRECAUTIONARY STATEMENTSHazards To Humans & Domestic AnimalsCAUTION: Harmful if absorbed through skin. Avoid inhalation of spray mist. Causes moderate eye irritation. Avoid contact with skin, eyes or clothing. Wash thoroughly with soap and water after handling and before eating, drinking, chewing gum, or using tobacco or the toilet. Remove and wash contaminated clothing before reuse.PHYSICAL OR CHEMICAL HAZARDSContents under pressure. Do not use or store near heat or open flame. Do not puncture or incinerate container. Exposure to temperatures above 130°F (54°C) may cause bursting.DIRECTIONS FOR USEIt is a violation of Federal law to use this product in a manner inconsistent with its labeling.Use Restrictions: •Do not allow adults, children, or pets to enter until vapors, mists and aerosols have dispersed, and the treated area has been thoroughly ventilated. •Do not allow adults, children, or pets to enter the treated area until sprays have dried. •In the home, cover all food processing surfaces and utensils during treatment and thoroughly wash before use. Cover or remove exposed food. •Remove pets, birds and cover any water inhabited by fish (such as aquariums and ornamental fish ponds) before application. Turn off aquarium filtering systems before spraying and wait approximately 15 minutes after application before turning the filter back on. •This product is not for use on humans. If lice infestations should occur on humans, use a product labeled for use on humans. •Application is prohibited directly into sewers or drains, or to any area like a gutter where drainage to sewers, storm drains, water bodies, or aquatic habitat can occur. Do not allow the product to enter any drain during or after application. •Not for broadcast use on indoor residential surfaces.SHAKE WELL BEFORE USINGRemove protective cap. Hold container upright with nozzle away from you. Depress valve and spray from a distance of 12 to 15 inches for baseboards, moldings and when applying to floors as a spot spray and 8 to 10 inches for clothing, furniture and bedding. Test product on an inconspicuous area before applying to check for possible staining or discoloration. Inspect again after drying. Spray to the point of dampness but not run-off. Over application may cause damage. Will not stain surfaces or fabrics where water alone causes no damage.To kill Lice and Louse eggs: Clean home. Use this product for non-washable items only. Washables should be washed in hot water and dried in high heat. Spray only those articles and parts of bedding, including mattresses and furniture that cannot be either laundered or dry-cleaned. Do not use on sheets or pillowcases. Allow all sprayed articles to dry thoroughly before use. If lice infestation occurs on humans, use a product labeled for use on humans.Bedbugs: Spray mattresses, particularly around tufts and seams. Take beds apart and spray into all joints. Treat baseboards, moldings and floors. Spray to the point of dampness but not run-off. After mattress is dry, cover with mattress cover and sheet. Do not use mattress without cover. Retreat if infestation occurs, but not more than once every two weeks.To control House Dust Mites (Dermatophagoides spp.): This product controls house dust mites that may cause asthma, hay fever, rhinitis, watery eyes and sneezing. One treatment lasts for up to 8 weeks. On Upholstered Furniture – Test fabric in an inconspicuous area to insure dyes will not bleed. Hold container upright with nozzle away from you. Depress valve and spray from a distance of 8 to 10 inches. Spray all fabric surfaces until damp. Spray to the point of dampness but not run-off. Do not use on delicate fabrics. Allow furniture to dry thoroughly before using. On Carpets – Apply as a spot spray to areas where dust mites are likely (including along baseboards and moldings). Hold nozzle approximately 12 to 18 inches from the carpet surface. Spray until damp. After application, brush the surface of the carpet with a broom or brush to insure deep penetration. Allow carpet to dry thoroughly before reentering the treated area. Drying time can be accelerated by using a fan. On Mattresses – Spray the top, bottom and sides of mattresses until damp, paying particular attention to tufts and seams. Allow to dry thoroughly before using. After mattress is dry, cover with mattress cover and sheet. Do not use mattress without cover. Vacuum entire area once dry. Since vacuuming stirs dust up in the air those with allergies should have another person vacuum or should wear a dust mask and use vacuum with a high efficiency particulate (HEPA) filter.STORAGE AND DISPOSALDo not contaminate water, food or feed by storage or disposal.Pesticide Storage: Store in a cool, dry area away from children and pets and away from heat, sparks and open flame. Do not transport or store below 32°F (0°C). Protect from freezing. Do not freeze.Pesticide Disposal and Container Handling: Do Not Puncture or Incinerate.If empty: Place in trash or offer for recycling if available.If partly filled: Call your local solid waste agency or 1-800-CLEANUP (253-2687) for disposal instructions. Never place unused product down any indoor or outdoor drain.To the extent consistent with applicable law, purchaser assumes all responsibility for safety and use not in accordance with directions.See carton for EPA numbers.

* Please review the disclaimer below.