Topcare
FDA Label NDC 36800-618

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 36800-618). 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, ask a doctor before using if you have, when using this product, stop use and ask a doctor if, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

SELENIUM SULFIDE 1%

Purpose

ANTI-DANDRUFF, ANTI-SEBORRHEIC DERMATITIS

Uses

HELPS PREVENT THE CHANCE OF RECURRENCE OF FLAKING, ITCHING, IRRITATION, SCALING AND REDNESS ASSOCIATED WITH DANDRUFF AND SEBORRHEIC DERMATITIS

Warnings

FOR EXTERNAL USE ONLY

Ask A Doctor Before Using If You Have

SEBORRHEIC DERMATITIS IN AREAS OTHER THAN THE SCALP

When Using This Product

AVOID CONTACT WITH EYES. IF CONTACT OCCURS, RINSE EYES THOROUGHLY WITH WATER. FOR USE ON COLOR TREATED OR PERMED HAIR, RINSE THOROUGHLY

Stop Use And Ask A Doctor If

CONDITION WORSENS OR DOES NOT IMPROVE AFTER REGULAR USE OF THIS PRODUCT AS DIRECTED

Directions

SHAKE WELL. APPLY SHAMPOO, RINSE THOROUGHLY. FOR BEST RESULTS, USE AT LEAST TWICE A WEEK OR AS DIRECTED BY A DOCTOR

Inactive Ingredients

WATER (AQUA), AMMONIUM LAURETH SULFATE, AMMONIUM LAURYL SULFATE, GLYCOL DISTEARATE, COCAMIDE MEA, AMMONIUM XYLENESULFONATE, ACRYLATES COPOLYMER, SODIUM HYDROXIDE, SODIUM CITRATE, FRAGRANCE (PARFUM), DIMETHICONE, CETYL ALCOHOL, SODIUM CHLORIDE, CITRIC ACID, SODIUM BENZOATE, STEARYL ALCOHOL, DISODIUM EDTA, HYDROXYPROPYL METHYLCELLULOSE, METHYLCHLOROISOTHIAZOLINONE, METHYLISOTHIAZOLINONE, RED 4 (CI 14700)

Label Copy

Image Of The Label (19688l)

Image Of The Label (19688l)

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