NDC 63517-253 Leader Lice Killing

Piperonyl Butoxide, Pyrethrum Extract

NDC Product Code 63517-253

NDC 63517-253-04

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

NDC Product Information

Leader Lice Killing with NDC 63517-253 is a a human over the counter drug product labeled by Cardinal Health. The generic name of Leader Lice Killing is piperonyl butoxide, pyrethrum extract. The product's dosage form is shampoo and is administered via topical form.

Labeler Name: Cardinal Health

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.

Leader 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.

  • WATER (UNII: 059QF0KO0R)
  • ALCOHOL (UNII: 3K9958V90M)
  • POLYQUATERNIUM-10 (400 MPA.S AT 2%) (UNII: HB1401PQFS)
  • PEG-25 HYDROGENATED CASTOR OIL (UNII: 0ZNO9PJJ9J)
  • AMMONIUM LAURETH-2 SULFATE (UNII: 698O4Z48G6)

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: Cardinal Health
Labeler Code: 63517
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: 02-21-2019 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.

Leader 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 Ingredient

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

Uses

Treats head, pubic (crab), and body lice

Purpose

Lice treatment

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 into 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.

Directions

  • Important: Read warnings before useAdults and children 2 years and over:Inspectcheck 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 productTreatapply 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 the 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 treatments
  • Children under 2 years: ask a doctor

Other Information

  • Do not freezestore at controlled room temperature 20°-25°C (68°-77°F)to report serious side effects due to the use of this product call 515-276-1586see package insert for additional information

Inactive Ingredients

Ammonium laureth sulfate, fragrance, PEG-25 hydrogenated castor oil, polyquaternium-10, purified water, SD-40 alcohol

* Please review the disclaimer below.

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