drug facts

drug facts
SPL v1
SPL
SPL Set ID d217d3c3-8249-4d8b-adf5-d518bd5161d5
Route
topical
Published
Effective Date 2014-08-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
selenium sulfide (10 mg)
Inactive Ingredients
water sodium laureth sulfate tea-lauryl sulfate cocamidopropyl betaine methacrylic acid - methyl methacrylate copolymer (1:1) citric acid monohydrate ammonium chloride dmdm hydantoin menthol sodium hydroxide magnesium aluminum silicate hypromelloses fd&c blue no. 1 d&c red no. 33

Identifiers & Packaging

Marketing Status
otc monograph final active Since 2014-08-17
Purpose

ANTI-DANDRUFF

Description

SELENIUM SULFIDE 1%

Medication Information

Warnings

FOR EXTERNAL USE ONLY

Uses

FOR RELIEF OF FLAKING AND ITCHING ASSOCIATED WITH DANDRUFF AND SEBORRHEIC DERMATITIS AND TO HELP PREVENT THE CHANCE OF RECCURENCE

Purpose

ANTI-DANDRUFF

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

STORE AT ROOM TEMPERATURE

Inactive Ingredients

WATER (AQUA), SODIUM LAURETH SULFATE, TEA-LAURYL SULFATE, COCAMIDOPROPYL BETAINE, ACRYLATES COPOLYMER, CITRIC ACID, FRAGRANCE, AMMONIUM CHLORIDE, DMDM HYDANTOIN, MENTHOL, SODIUM HYDROXIDE, MAGNESIUM ALUMINUM SILICATE, HYDROXYPROPYL METHYLCELLULOSE, BLUE 1 (CI 42090), RED 33 (CI 17200)

Description

SELENIUM SULFIDE 1%

Questions?

CALL: 1-888-287-1915

Label Copy

Active Ingredient

SELENIUM SULFIDE 1%

When Using This Product
  • AVOID CONTACT WITH EYES
  • IF PRODUCT GETS INTO EYES, RINSE 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

IN CASE OF ACCIDENTAL INGESTION, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY

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

Uses (USES)

FOR RELIEF OF FLAKING AND ITCHING ASSOCIATED WITH DANDRUFF AND SEBORRHEIC DERMATITIS AND TO HELP PREVENT THE CHANCE OF RECCURENCE

Purpose (PURPOSE)

ANTI-DANDRUFF

Directions (DIRECTIONS)
  • SHAKE WELL, APPLY SHAMPOO, RINSE THOROUGHLY
  • FOR BEST RESULTS USE AT LEAST TWICE A WEEK OR AS DIRECTED BY A DOCTOR
Other Information (OTHER INFORMATION)

STORE AT ROOM TEMPERATURE

Inactive Ingredients (INACTIVE INGREDIENTS)

WATER (AQUA), SODIUM LAURETH SULFATE, TEA-LAURYL SULFATE, COCAMIDOPROPYL BETAINE, ACRYLATES COPOLYMER, CITRIC ACID, FRAGRANCE, AMMONIUM CHLORIDE, DMDM HYDANTOIN, MENTHOL, SODIUM HYDROXIDE, MAGNESIUM ALUMINUM SILICATE, HYDROXYPROPYL METHYLCELLULOSE, BLUE 1 (CI 42090), RED 33 (CI 17200)

Questions? (QUESTIONS?)

CALL: 1-888-287-1915

Label Copy (LABEL COPY)

Active Ingredient (ACTIVE INGREDIENT)

SELENIUM SULFIDE 1%

When Using This Product (WHEN USING THIS PRODUCT)
  • AVOID CONTACT WITH EYES
  • IF PRODUCT GETS INTO EYES, RINSE 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)

IN CASE OF ACCIDENTAL INGESTION, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY

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: 2026-02-15T11:55:49.453387 · Updated: 2026-03-14T22:53:47.887144