Active Ingredient
PYRITHIONE ZINC 1%
Topcare
FDA Label NDC 36800-333
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Topco Associates Llc for the product Topcare (NDC 36800-333). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient, purpose, uses, warnings, when using this product, stop use and ask a doctor if, keep out of reach of children, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
ANTI-DANDRUFF
Uses
TO HELP PREVENT RECURRENCE OF FLAKING AND ITCHING ASSOCIATED WITH DANDRUFF
Warnings
FOR EXTERNAL USE ONLY
When Using This Product
AVOID CONTACT WITH EYES. IF CONTACT OCCURS, RINSE EYES THOROUGHLY WITH WATER
Stop Use And Ask A Doctor If
CONDITION WORSENS OR DOES NOT IMPROVE AFTER REGULAR USE OF THIS PRODUCT AS DIRECTED
Keep Out Of Reach Of Children
IN CASE OF ACCIDENTAL INGESTION, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY
Directions
FOR MAXIMUM DANDRUFF CONTROL, USE EVERY TIME YOU SHAMPOO. WET HAIR, MASSAGE ONTO SCALP AND RINSE. REPEAT IF DESIRED
Inactive Ingredients
WATER (AQUA), SODIUM LAURETH SULFATE, SODIUM LAURYL SULFATE, DIMETHICONE, COCAMIDE MEA, ZINC CARBONATE, GLYCOL DISTEARATE, SODIUM XYLENESULFONATE, FRAGRANCE (PARFUM), CETYL ALCOHOL, GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE, MAGNESIUM SULFATE, SODIUM CHLORIDE, SODIUM BENZOATE, MAGNESIUM CARBONATE HYDROXIDE, BENZYL ALCOHOL, PRUNUS AMYGDALUS DULCIS (SWEET ALMOND) OIL, CITRIC ACID, METHYLCHLOROISOTHIAZOLINONE, METHYISOTHIAZOLINONE, BLUE 1 (CI 42090), YELLOW 5 (CI 19140)
Label Copy
Image Of The Label (19678l)
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