NDC 73280-000 Ki-tapiox Lice Treatment

Pyrethrum, Piperonyl Butoxide

NDC Product Code 73280-000

NDC 73280-000-04

Package Description: 120 mL in 1 BOTTLE

NDC Product Information

Ki-tapiox Lice Treatment with NDC 73280-000 is a a human over the counter drug product labeled by Certus Pharma S.a. De C.v.. The generic name of Ki-tapiox Lice Treatment is pyrethrum, piperonyl butoxide. The product's dosage form is liquid and is administered via topical form.

Labeler Name: Certus Pharma S.a. De C.v.

Dosage Form: Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.

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.

Ki-tapiox Lice Treatment 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.

  • PYRETHRUM EXTRACT 1.7 mg/mL
  • PIPERONYL BUTOXIDE 20 mg/mL

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)
  • SODIUM LAURETH-3 SULFATE (UNII: BPV390UAP0)
  • COCO DIETHANOLAMIDE (UNII: 92005F972D)
  • COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
  • UREA (UNII: 8W8T17847W)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • DIETHYLENE GLYCOL DISTEARATE (UNII: 617Q4OD69O)
  • SODIUM BENZOATE (UNII: OJ245FE5EU)
  • POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600000 MW) (UNII: 0L414VCS5Y)

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: Certus Pharma S.a. De C.v.
Labeler Code: 73280
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: 11-01-2019 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.

Ki-tapiox Lice Treatment Product Label Images

Ki-tapiox Lice Treatment 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

Pyrethrum Extract (pyrethrins) 0.17%


Piperonyl Butoxide 2%

Purpose

Pediculicide

Use

Treats head, pubic (crab), and body lice

Warnings

For external use only

Do Not Use

  • Near eyesinside nose, mouth, or vaginaon 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 Prdouct

  • Keep eyes tightly closed and protect eyes with a washcloth to towelif product gets in eyes, flush with water right awayscalp itching or redness may occur

Stop Use And Ask A Doctor If

  • Breathing difficulty occurseye irritation occursskin 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 brightlight for lice/nits (eggs)look for tiny nits near scalp, beginning at back of neck and behind earsexamine small sections of hair at a timeunlike dandruff which moves when touched, nits stick to the hairif either lice or nits are found, treat with this product.Treatapply thoroughly to hair or other affected area. For head lice, firstapply behind ears and to back of neck.allow product to remain for 10 minutes, but no longerwash area thoroughly with warm water and soap or shampoofor 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 remainingnits by hand (using a throw-away glove).hair should remain slightly damp while removing nitsif hair dries during combing, dampen slightly with waterfor 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 combingclean comb often. Wipe nits away with tissue and discard in a plastin bag. Seal bag and discard to prevent lice from coming back.after coming, thoroughly recheck for lice/nits. Repeat combing if necessary.check daily for any lice/nits that you misseda 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

Inactive Ingredients Headings

Water, Sodium Lauryl Ether Sulfate, Cocodiethanolamide, Cocamidopropyl Betaine, Urea, Quassia Amara Vinegar, Glycerin, Ethylene Glycol Distearate, Sodium Benzoate, Polyquaternium 7, Fragrance.

* Please review the disclaimer below.