Label: EQUALINE MOISTURIZING DANDRUFF- selenum 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 March 26, 2012

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  • ACTIVE INGREDIENT

    SELENIUM SULFIDE 1%

    PURPOSE

    ANTIDANDRUFF

  • 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 EYES. IF PRODUCT GETS INTO EYES, RINSE THOROUGHLY WITH WATER. FOR USE ON COLOR TREATED OR PERMED HAIR, RINSE THOROUGHLY.

    STOP USING THIS PRODUCT AND ASK 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.

  • QUESTIONS? COMMENTS?

    1-877-932-7948

  • INACTIVE INGREDIENTS

    WATER (AQUA), AMMONIUM LAURYL SULFATE, AMMONIUM LAURETH SULFATE, DIHYDROGENATED TALLOW PHTHALIC ACID AMIDE, COCAMIDE MEA, FRAGRANCE (PARFUM), TITANIUM DIOXIDE, DIMETHICONE, HYDROXYPROPYL METHYLCELLULOSE, CITRIC ACID, SODIUM ISOSTEAROYL LACTYLATE, DMDM HYDANTOIN, ALOE BARBADENSIS LEAF JUICE, SODIUM CITRATE, SODIUM CHLORIDE, BLUE 1 (CI 42090).

  • LABEL COPY

    IMAGE OF THE LABEL

  • INGREDIENTS AND APPEARANCE
    EQUALINE  MOISTURIZING DANDRUFF
    selenum sulfide shampoo
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41163-616
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SELENIUM SULFIDE (UNII: Z69D9E381Q) (SELENIUM - UNII:H6241UJ22B) SELENIUM SULFIDE1 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    AMMONIUM LAURYL SULFATE (UNII: Q7AO2R1M0B)  
    AMMONIUM LAURETH-5 SULFATE (UNII: 43ZIH89I48)  
    DIHYDROGENATED TALLOW PHTHALIC ACID AMIDE (UNII: 1R81RPY10G)  
    COCO DIETHANOLAMIDE (UNII: 92005F972D)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    HYPROMELLOSE 2208 (100 MPA.S) (UNII: B1QE5P712K)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    SODIUM ISOSTEAROYL LACTYLATE (UNII: 8730J0D3EV)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:41163-616-11325 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart358H03/23/2012
    Labeler - SUPERVALU INC. (006961411)
    Registrant - APOLLO HEALTH AND BEAUTY CARE (201901209)
    Establishment
    NameAddressID/FEIBusiness Operations
    APOLLO HEALTH AND BEAUTY CARE201901209manufacture
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