Drug Facts Box - Back Label

Drug Facts Box - Back Label
SPL v1
SPL
SPL Set ID 7333f325-5d46-4a1d-a50b-aef26a37a2a6
Route
TOPICAL
Published
Effective Date 2010-09-29
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Selenium (1 mL)
Inactive Ingredients
Water Ammonium Lauryl Sulfate Trolamine Lauryl Sulfate Ammonium Laureth-5 Sulfate Cocamidopropyl Betaine Magnesium Aluminum Silicate Menthol Coco Diethanolamide Dmdm Hydantoin Citric Acid Monohydrate Hydroxypropyl Cellulose Sodium Chloride Sodium Citrate D&c Red No. 33 Fd&c Blue No. 1

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2010-09-29
Description

SELENIUM SULFIDE 1%

Purpose

ANTI DANDRUFF

Medication Information

Purpose
  • ANTI DANDRUFF
Description

SELENIUM SULFIDE 1%

Use

FOR RELIEF OF FLAKING AND ITCHING DUE TO DANDRUFF, AND SEBORRHEIC DERMATITIS, AND TO HELP PREVENT THE CHANCE OF RE-OCCURRENCE.

Warnings
  • FOR EXTERNAL USE ONLY.

Directions
  • SHAKE WELL, SHAMPOO, THEN RINSE THROUGHLY.
  • FOR BEST RESULTS, USE AT LEAST TWICE A WEEK OR AS DIRECTED BY A DOCTOR.



Active Ingredient

SELENIUM SULFIDE 1%



Inactive Ingredients
WATER, AMMONIUM LAURYL SULFATE, TEA-LAURYL SULFATE, AMMONIUM LAURETH SULFATE, COCAMIDOPROPYL BETAINE, MAGNESIUM ALUMINUM SILICATE, FRAGRANCE, MENTHOL, COCAMIDE DEA, DMDM HYDANTOIN, CITRIC ACID, HYDROXYPROPYL METHYLCELLULOSE, SODIUM CITRATE, SODIUM CHLORIDE, BLUE 1 (CI 42090), RED 33 (CI 17200)

When Using This Product
  • AVOID CONTACT WITH THE 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.

Keep Out of Reach of Children
  • IF SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.

Package Front and Back Labels

tc11.jpg

Ask A Doctor Before Using If You Have

SEBORRHEIC DERMATITIS IN AREAS OTHER THAN THE SCALP

Structured Label Content

Use (USE)

FOR RELIEF OF FLAKING AND ITCHING DUE TO DANDRUFF, AND SEBORRHEIC DERMATITIS, AND TO HELP PREVENT THE CHANCE OF RE-OCCURRENCE.

Purpose (PURPOSE)
  • ANTI DANDRUFF
Warnings (WARNINGS)
  • FOR EXTERNAL USE ONLY.

Directions (DIRECTIONS)
  • SHAKE WELL, SHAMPOO, THEN RINSE THROUGHLY.
  • FOR BEST RESULTS, USE AT LEAST TWICE A WEEK OR AS DIRECTED BY A DOCTOR.



Active Ingredient (ACTIVE INGREDIENT)

SELENIUM SULFIDE 1%



Inactive Ingredients (INACTIVE INGREDIENTS)
WATER, AMMONIUM LAURYL SULFATE, TEA-LAURYL SULFATE, AMMONIUM LAURETH SULFATE, COCAMIDOPROPYL BETAINE, MAGNESIUM ALUMINUM SILICATE, FRAGRANCE, MENTHOL, COCAMIDE DEA, DMDM HYDANTOIN, CITRIC ACID, HYDROXYPROPYL METHYLCELLULOSE, SODIUM CITRATE, SODIUM CHLORIDE, BLUE 1 (CI 42090), RED 33 (CI 17200)

When Using This Product (WHEN USING THIS PRODUCT)
  • AVOID CONTACT WITH THE 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 (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 (KEEP OUT OF REACH OF CHILDREN)
  • IF SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.

Package Front and Back Labels (PACKAGE FRONT AND BACK LABELS)

tc11.jpg

Ask A Doctor Before Using If You Have (ASK A DOCTOR BEFORE USING IF YOU HAVE)

SEBORRHEIC DERMATITIS IN AREAS OTHER THAN THE SCALP

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:55:09.438770 · Updated: 2026-03-14T22:52:30.292621