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
Purpose

ANTI DANDRUFF

Description

SELENIUM SULFIDE 1%

Medication Information

Warnings
  • FOR EXTERNAL USE ONLY.

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



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)

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.

Active Ingredient

SELENIUM SULFIDE 1%



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

Warnings (WARNINGS)
  • FOR EXTERNAL USE ONLY.

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



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)

Use (USE)

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

Active Ingredient (ACTIVE INGREDIENT)

SELENIUM SULFIDE 1%



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