Label: REXALL ALOE- selenium sulfide liquid

  • 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 September 25, 2012

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  • ACTIVE INGREDIENT

    SELENIUM SULFIDE 1%

    PURPOSE

    ANTI-DANDRUFF

  • USES

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

  • WARNINGS

    FOR EXTERNAL USE ONLY.

    ASK A DOCTOR BEFORE USE IF YOU HAVE

    SEBORRHEIC DERMATITIS IN AREAS OTHER THAN THE SCALP.

    WHEN USING THIS PRODUCT

    STOP USE AND ASK A DOCTOR IF

    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, AND 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), AMMONIUM LAURYL SULFATE, AMMONIUM LAURETH SULFATE, DIHYDROGENATED TALLOW PHTALIC ACID AMIDE, COCAMIDE DEA, 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).

  • PRINCIPAL DISPLAY PANEL

    IMAGE OF THE LABEL

  • INGREDIENTS AND APPEARANCE
    REXALL  ALOE
    selenium sulfide liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55910-616
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SELENIUM SULFIDE (UNII: Z69D9E381Q) (SELENIUM SULFIDE - UNII:Z69D9E381Q) SELENIUM SULFIDE1 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    AMMONIUM LAURYL SULFATE (UNII: Q7AO2R1M0B)  
    AMMONIUM LAURETH-3 SULFATE (UNII: 896SJ235FN)  
    DIHYDROGENATED TALLOW PHTHALIC ACID AMIDE (UNII: 1R81RPY10G)  
    COCO DIETHANOLAMIDE (UNII: 92005F972D)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    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:55910-616-11325 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart358H09/25/2012
    Labeler - DOLGENCORP INC. (068331990)
    Registrant - APOLLO HEALTH AND BEAUTY CARE (201901209)
    Establishment
    NameAddressID/FEIBusiness Operations
    APOLLO HEALTH AND BEAUTY CARE201901209manufacture(55910-616)
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