NDC 0113-0866 Good Sense Lice Killing

Piperonyl Butoxide, Pyrethrum Extract

NDC Product Code 0113-0866

NDC 0113-0866-26

Package Description: 1 BOTTLE in 1 CARTON > 118 mL in 1 BOTTLE

NDC Product Information

Good Sense Lice Killing with NDC 0113-0866 is a a human over the counter drug product labeled by L. Perrigo Company. The generic name of Good Sense Lice Killing is piperonyl butoxide, pyrethrum extract. The product's dosage form is shampoo and is administered via topical form.

Labeler Name: L. Perrigo Company

Dosage Form: Shampoo - A liquid soap or detergent used to clean the hair and scalp and is often used as a vehicle for dermatologic agents.

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.

Good Sense Lice Killing Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • PIPERONYL BUTOXIDE 4 g/100mL
  • PYRETHRUM EXTRACT .33 g/100mL

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)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.
  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.

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: 12-08-2007 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: 12-31-2021 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’.

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Information for Patients

Pyrethrin and Piperonyl Butoxide Topical

Pyrethrin and Piperonyl Butoxide Topical is pronounced as (pi reth' rin) (pi' per on il)

Why is pyrethrin and piperonyl butoxide topical medication prescribed?
Pyrethrin and piperonyl butoxide shampoo is used to treat lice (small insects that attach themselves to the skin on the head, body, or pubic area ['crabs']) in adults and...
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* Please review the disclaimer below.

Good Sense Lice Killing 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 useAdults 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 •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

  • Steps to Success with 1-2-3 Lice Control SystemComplete lice control for your family and home.STEP 1: TREATLice 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.STEP 2: REMOVELice/Nit CombCombing must be done AFTER use of Lice Killing Shampoo (Step 1). Combing out eggs & nits* is an essential step to complete lice control.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-detangler/conditioner to make combing easier •Find a distraction for your child (e.g. books, TV, game). •Apply detangler/conditioner and comb out damp hair with a regular wide-tooth comb to take out snarls and tangles. •Hold the Lice/Nit comb with the teeth facing you. •Working one section at a time, lift a 1- to 2- inch wide strand of hair. •Place comb as a close to the scalp as possible and comb with a firm, even motion away from scalp, from the roots to the end of the hair (newly-laid eggs are found near the roots of the hair so it is important to get the teeth very close to the scalp). Make sure the teeth are deeply embedded into the strands as you comb through. •Always comb away from the head. •Wipe eggs and nits from the teeth of the comb with a tissue or paper towel. •Pin back the 1- to 2-inch wide strand you just finished combing with a bobby pin or hair clip. •Lift up another 1- to 2-inch wide strand and repeat the combing procedure. •When one section has been combed and pinned, repeat the process for another section of hair. Continue to comb hair 1- to 2-inches at a time until entire head has been combed and pinned. •Keep the hair damp during combing and re-apply detangler/conditioner as needed. •After you have combed and pinned the entire head, remove all bobby pins or hair clips and rinse hair thoroughly with warm water. If desired, you may also wash with regular shampoo. •Discard all the used tissues or paper towels into a bag, seal and dispose to prevent lice from coming back.* Nits are empty eggshells left behind when lice hatch from eggs.STEP 3: CONTROLHome Lice, Bedbug & Dust Mite Spray •Use Home Lice, Bedbug & Dust Mite Spray to kill lice and their eggs on mattresses, furniture, car interiors and other non-washable items. A regular disinfectant spray will not kill lice and their eggs. •After spraying the infested area, vacuum rugs and carpets. Dispose of the vacuum cleaner bags after use. •Wash all clothes, towels, washable hats, scarves, coats and bed linens in hot water. Dry in high heat for at least 20 minutes. •Dry clean non-washables. •Personal combs and brushes may be disinfected by soaking in hot water [above 54°C (130°F)] for at least 10 minutes. •Place stuffed toys in plastic bags and seal them for 4 weeks.Checklist-Home and auto upholstery-Bike/sport helmets-Mattresses, pillows, pillowcases-Coats, scarves, earmuffs, gloves-Bed linen-Play mats-Towels-Clothing-Stuffed animals, toys-Barrettes/hair ornaments-Headphones-Hair rollers-Hats-Combs and brushes-Headbands-Baseball capsDaily CheckingTO PREVENT REINFESTATION: •Carefully inspect infested family member daily for at least 2 weeks. If you see eggs or nits, repeat Step 2. •Check other family members for Head Lice. If anyone in the family is infested, follow Step 1 and Step 2. Repeat Step 3 with any articles or items with which they have come into contact.Second ApplicationRepeat the same procedures within 7-10 days forStep 1: Treat and Step 2: RemoveThere may be some eggs that were not combed out after the first treatment. These eggs will hatch and need to be killed with the second treatment.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, such as a Home Lice, Bedbug & Dust Mite Spray. •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.Distributed ByPerrigo ®Allegan, MI 49010: 8660000J5Lice 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 useAdults 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 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? 800-719-9260

* Please review the disclaimer below.