NDC 0113-1910 Good Sense Lice Killing Creme Rinse

Permethrin

NDC Product Code 0113-1910

NDC Code: 0113-1910

Proprietary Name: Good Sense Lice Killing Creme Rinse 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: Permethrin 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
    • 0113-1910 - Good Sense Lice Killing Creme Rinse

NDC 0113-1910-16

Package Description: 1 BOTTLE in 1 CARTON > 59 mL in 1 BOTTLE

NDC Product Information

Good Sense Lice Killing Creme Rinse with NDC 0113-1910 is a a human over the counter drug product labeled by L. Perrigo Company. The generic name of Good Sense Lice Killing Creme Rinse is permethrin. The product's dosage form is lotion and is administered via topical form.

Labeler Name: L. Perrigo Company

Dosage Form: Lotion - An emulsion, liquid1 dosage form. This dosage form is generally for external application to the skin.2

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 Creme Rinse 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.

  • PERMETHRIN 1 mg/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.

  • BALSAM FIR LEAFY TWIG (UNII: H1TFV1454Z)
  • ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
  • BUTYLPARABEN (UNII: 3QPI1U3FV8)
  • CETETH-10 (UNII: LF9X1PN3XJ)
  • CETYL ALCOHOL (UNII: 936JST6JCN)
  • ETHYLPARABEN (UNII: 14255EXE39)
  • FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
  • ISOPROPYL ALCOHOL (UNII: ND2M416302)
  • METHYLPARABEN (UNII: A2I8C7HI9T)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • PROPYLPARABEN (UNII: Z8IX2SC1OH)
  • WATER (UNII: 059QF0KO0R)
  • STEARALKONIUM CHLORIDE (UNII: 0OUO26BB88)

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.

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: ANDA076090 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: ANDA - A product marketed under an approved Abbreviated New Drug Application. 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: 07-24-2019 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 Lice Killing Creme Rinse 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 Ingredient (In Each Fluid Ounce)

Permethrin 280 mg (1%)

Purpose

Lice treatment

Use

Treats head lice

Warnings

For external use only

Do Not Use

  • •on children under 2 months of age •near the eyes •inside the nose, ear, mouth, or vagina •on lice in eyebrows or eyelashes.See your doctor.

Ask A Doctor Before Use If You Are

  • •allergic to ragweed. May cause breathing difficulty or an asthmatic episode.

When Using This Product

  • •keep eyes tightly closed and protect eyes with a washcloth or towel •if product gets into the eyes, immediately flush with large amounts of water •scalp itching or redness may occur

Stop Use And See A Doctor If

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

If Pregnant Or Breast-Feeding,

Ask a health professional before use.

Keep Out Of Reach Of Children.

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

Directions

  • Inspect •all household members should be checked by another person for lice and/or nits (eggs) •use a magnifying glass in bright light to help you see the lice and nits (eggs) •use a tool, such as a comb or two unsharpened pencils to lift and part the hair •look for tiny nits near the scalp, beginning at the back of the neck and behind the ears •small sections of hair (1-2 inches wide) should be examined at a time •unlike dandruff, nits stick to the hair. Dandruff should move when lightly touched. •if either lice or nits (eggs) are found, treat with the creme rinseTreat •wash hair with a shampoo without conditioner. Do not use a shampoo that contains a conditioner or a conditioner alone since this may decrease the activity of the creme rinse. Rinse with water. •towel dry hair so it is damp but not wet •shake the bottle well •completely saturate the hair and scalp with the creme rinse. Begin to apply the creme rinse behind the ears and at the back of the neck. •keep the creme rinse out of the eyes. Protect the eyes with a washcloth or towel. •leave the creme rinse on the hair for 10 minutes, but no longer •rinse with warm water •towel dry hair and comb out tangles •if live lice are seen seven days or more after the first treatment, a second treatment should be givenRemove Lice/Nits •remove nits by combing the hair with the special small tooth comb provided. Remaining nits may be removed by hand (using a throw-away glove), or cutting the nits out. •use the nit comb provided and make sure the hair remains slightly damp while removing nits •if the hair dries during combing, dampen it slightly with water •part the hair into 4 sections. Work on one section at a time. Longer hair may take more time (1-2 hours). •start at the top of the head on the section you have picked •with one hand, lift a 1-2 inch wide strand of hair. Get the teeth of the comb as close to the scalp as possible and comb with a firm, even motion away from the scalp to the end of the hair. •use clips to pin back each strand of hair after you have combed out the nits •clean the comb completely as you go. Wipe the nits from the comb with a tissue and throw away the tissue in a sealed plastic bag to prevent the lice from coming back. •after combing, recheck the entire head for nits and repeat combing if necessary •check the affected head daily to remove any nits that you might have missed

Other Information

  • •read all the directions and warnings in the Consumer Information Insert before use. Keep the carton. It contains important information. •store at 20 to 25°C (68 to 77°F)

Inactive Ingredients

Abies balsamea (balsam canada) extract, anhydrous citric acid, butylparaben, ceteth-10, cetyl alcohol, ethylparaben, FD&C yellow no. 6, fragrance, hydrolyzed animal protein, hydroxyethyl cellulose, isopropyl alcohol, methylparaben, phenoxyethanol, propylene glycol, propylparaben, purified water, stearalkonium chloride

Consumer Information

  • Permethrin Lotion, 1%Lice Treatment Creme RinseTHE FACTS OF LICEPlease read all information before using Lice Treatment Creme Rinse.If you or a member of your household has head lice, don’t panic. Keep calm.Anyone can get head lice - it has nothing to do with cleanliness or poor hygiene. Head lice are treatable and very rarely cause serious health problems.What are head lice? •head lice are small insects that live and feed on the human scalp •they may get as big as sesame seeds and are brown •lice do not fly or jump from one person to another. They can only crawl.What are nits? •nits are lice eggs laid on the hair near the scalp. One louse may lay over 100 nits. •nits are oval shaped, tiny and greyish-white •they are attached to hair with a waterproof glue-like substance that cannot be washed out or blown awayBecause nits (eggs) hatch in about one week, all nits must be removed to stop lice.How do head lice spread? •head lice spread easily from close head-to-head or hand-to-head contact with persons who have lice •they may also spread by sharing hats, helmets, scarves, headphones, brushes, combs, bedding and clothingHow do you know if you have lice? •itching is the most common symptom •scratching behind the ears or the back of the neck is a sign that you should check for head lice •scabs or blood spots may be seenHow do you prevent the spread of lice? •do not share or borrow personal items like combs, brushes, or headbands •do not share or borrow hats, sweaters, coats, scarves, helmets, headphones, pillows or stuffed animals •store hats in coat sleeves and hang coats separately, so that they do not touch other people’s hats and coats •wash under fingernails when you first see lice or nits (eggs) •check your child’s head daily when you hear of a lice outbreak in day care or schoolHow to use the creme rinseI. InspectIf you suspect head lice - check. Head lice may be hard to locate because they avoid light. Nits are easier to see. •all household members should be checked by another person for lice and/or nits (eggs) •use a magnifying glass in bright light to help you see the lice and nits (eggs) •use a tool, such as a comb or two unsharpened pencils to lift and part the hair •look for tiny nits near the scalp, beginning at the back of the neck and behind the ears •small sections of hair (1-2 inches wide) should be examined at a time •unlike dandruff, nits stick to the hair. Dandruff should move when lightly touched. •if either lice or nits (eggs) are found, treat with the creme rinseII. Treat •wash hair with a shampoo without conditioner. Do not use a shampoo that contains a conditioner or a conditioner alone since this may decrease the activity of the creme rinse. Rinse with water. •towel dry hair so it is damp but not wet •shake the bottle well •completely saturate the hair and scalp with the creme rinse. Begin to apply the creme rinse behind the ears and at the back of the neck. •keep the creme rinse out of the eyes. Protect the eyes with a washcloth or towel. •leave the creme rinse on the hair for 10 minutes, but no longer •rinse with warm water •towel dry hair and comb out tangles •if live lice are seen seven days or more after the first treatment, a second treatment should be givenIII. Remove Lice/NitsTreatment kills lice but does not remove the nits. •remove nits by combing the hair with the special small tooth comb provided. Remaining nits may be removed by hand (using a throw-away glove), or cutting the nits out. •use the nit comb provided and make sure the hair remains slightly damp while removing nits •if the hair dries during combing, dampen it slightly with water •part the hair into 4 sections. Work on one section at a time. Longer hair may take more time (1-2 hours). •start at the top of the head on the section you have picked •with one hand, lift a 1-2 inch wide strand of hair. Get the teeth of the comb as close to the scalp as possible and comb with a firm, even motion away from the scalp to the end of the hair. •use clips to pin back each strand of hair after you have combed out the nits •clean the comb completely as you go. Wipe the nits from the comb with a tissue and throw away the tissue in a sealed plastic bag to prevent the lice from coming back. •after combing, recheck the entire head for nits and repeat combing if necessary •check the affected head daily to remove any nits that you might have missedIV. Clean home and personal itemsAfter using the creme rinse, it is very important to clean personal items and your home to prevent the spread of lice. Nits may live away from the human head for about 7-12 days. Lice may live away from the human head for about 1 day. •all personal head gear (hats, hair ribbons, etc.), scarves, coats, towels and bed linens should be washed in hot water (above 130°F), then dried in the dryer using the hottest cycle for at least 20 minutes •personal combs, including nit combs, and brushes should be soaked in hot water (above 130°F) for at least 10 minutes •personal articles such as clothing, bedspreads, blankets, pillows or stuffed animals that cannot be washed should be dry-cleaned or sealed tightly in a plastic bag for a period of at least 4 weeks. Items should be taken out of the plastic bag outdoors and shaken out very hard before using again. •for anything you cannot wash, dry-clean or store in a plastic bag, spray with lice control spray. •vacuum everywhere. Vacuum all carpets, mattresses, upholstered furniture and car seats that may have been used by infested household members.WarningsFor external use onlyDo not use •on children under 2 months of age •near the eyes •inside the nose, ear, mouth, or vagina •on lice in eyebrows or eyelashes. See your doctor.Ask a doctor before use if you are •allergic to ragweed. May cause breathing difficulty or an asthmatic episode.When using this product •keep eyes tightly closed and protect eyes with a washcloth or towel •if product gets into the eyes, immediately flush with large amounts of water •scalp itching or redness may occurStop use and see a doctor if •breathing difficulty occurs •eye irritation occurs •skin or scalp irritation continues or infection occursIf pregnant or breast-feeding,ask a health professional before use.Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center right away. (1-800-222-1222)Question or comments?1-800-719-9260Distributed ByPerrigo®Allegan, MI 49010:95500 00 J2

* Please review the disclaimer below.

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