FDA.reportPublic FDA data

KI-TAPIOX LICE TREATMENT

Manufacturer
Certus Pharma S.A. de C.V.
Effective date
2019-08-14
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 00:03:33

Label at a glance#

ProductKI-TAPIOX LICE TREATMENT
Active ingredientPYRETHRUM EXTRACT, PIPERONYL BUTOXIDE
Label structure6 sections

Dosage and administration

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 ap...

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Pyrethrum Extract (pyrethrins) 0.17%
Piperonyl Butoxide 2%

Purpose

OTC - PURPOSE SECTION

Pediculicide

Use

INDICATIONS & USAGE SECTION

Treats head, pubic (crab), and body lice

Warnings

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

  • 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

OTC - ASK DOCTOR SECTION

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

When using this prdouct

OTC - WHEN USING SECTION

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

Stop use and ask a doctor if

OTC - STOP USE SECTION

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

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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

  • apply thoroughly to 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
  • wash area thoroughly with warm water and soap or shampoo
  • 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 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 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

Inactive Ingredients Headings

INACTIVE INGREDIENT SECTION

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

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
73280-00073280-000-04

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
SODIUM LAURETH-3 SULFATEBPV390UAP0IACT
COCO DIETHANOLAMIDE92005F972DIACT
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
UREA8W8T17847WIACT
GLYCERINPDC6A3C0OXIACT
DIETHYLENE GLYCOL DISTEARATE617Q4OD69OIACT
SODIUM BENZOATEOJ245FE5EUIACT
POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600000 MW)0L414VCS5YIACT
PYRETHRUM EXTRACTZUM06L90GVACTIB
PIPERONYL BUTOXIDELWK91TU9AHACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
c68aeeb0-896f-c28d-e053-2995a90ae8ba04931e54-ee6b-43ef-8828-aaef24c2dbed2021-07-07WarningsExact identifier
spl set id: 04931e54-ee6b-43ef-8828-aaef24c2dbed

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.