Label: MEDICATED DANDRUFF- selenium sulfide shampoo

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated August 19, 2011

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  • ACTIVE INGREDIENT

    SELENIUM SULFIDE 1%

  • PURPOSE

    ANTI-DANDRUFF

  • USES

    FOR RELIEF OF FLAKING AND ITCHING ASSOCIATED WITH DANDRUFF AND SEBORRHEIC DERMATITIS AND TO HELP PREVENT THE CHANCE OF RE-OCCURENCE.

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

    STOP USING THIS PRODUCT 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

    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, 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, RED 33.

  • QUESTIONS?

    CALL: 1-888-287-1915

  • Front and back labels

    image of label
  • INGREDIENTS AND APPEARANCE
    MEDICATED DANDRUFF   MAXIMUM STRENGTH
    selenium sulfide shampoo
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49035-610
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SELENIUM SULFIDE (UNII: Z69D9E381Q) (SELENIUM - UNII:H6241UJ22B) SELENIUM SULFIDE1.0000 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    AMMONIUM LAURYL SULFATE (UNII: Q7AO2R1M0B)  
    TROLAMINE LAURYL SULFATE (UNII: E8458C1KAA)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)  
    MENTHOL (UNII: L7T10EIP3A)  
    COCO DIETHANOLAMIDE (UNII: 92005F972D)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    AMMONIUM LAURETH-2 SULFATE (UNII: 698O4Z48G6)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49035-610-11325 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart358H08/19/2011
    Labeler - WAL-MART STORES INC (051957769)
    Registrant - APOLLO HEALTH AND BEAUTY CARE (201901209)
    Establishment
    NameAddressID/FEIBusiness Operations
    APOLLO HEALTH AND BEAUTY CARE201901209manufacture
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