Label: FRUITOPIA- pyrithione zinc 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 February 17, 2012

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  • ACTIVE INGREDIENT

    PYRITHIONE ZINC 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.

  • WHEN USING THIS PRODUCT

    AVOID CONTACT WITH EYES. IF PRODUCT GETS INTO EYES, RINSE THOROUGHLY WITH WATER.

  • 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

    APPLY SHAMPOO ON WET HAIR, RINSE THOROUGHLY. FOR BEST RESULTS, USE AT LEAST TWICE A WEEK OR AS DIRECTED BY A DOCTOR.

  • QUESTIONS? COMMENTS?

    1-866-428-7327

  • INACTIVE INGREDIENTS

    WATER (AQUA), AMMONIUM LAURETH SULFATE, AMMONIUM LAURYL SULFATE, SODIUM CHLORIDE, GLYCOL DISTEARATE, DIMETHICONE, CITRIC ACID, SODIUM CITRATE, AMMONIUM XYLENESULFONATE, COCAMIDE MEA, FRAGRANCE (PARFUM), GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE, SODIUM BENZOATE, POLYQUATERNIUM-10, PEG-7M, DMDM HYDANTOIN, TETRASODIUM EDTA, PROPYLENE GLYCOL, BENZYL ALCOHOL, CUCUMIS SATIVUS (CUCUMBER) FRUIT EXTRACT, CYMBOPOGON SCHOENANTHUS EXTRACT, MINERAL OIL, SODIUM POLYNAPHTHALENESULFONATE, METHYLCHLOROISOTHIAZOLINONE, METHYLISOTHIAZOLINONE, POTASSIUM SORBATE, BLUE 1 (CI 42090),  RED 33 (CI 17200).

  • LABEL COPY

    IMAGE OF THE LABEL

  • INGREDIENTS AND APPEARANCE
    FRUITOPIA 
    pyrithione zinc liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59779-421
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5) PYRITHIONE ZINC1.0 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    AMMONIUM LAURETH-2 SULFATE (UNII: 698O4Z48G6)  
    AMMONIUM LAURYL SULFATE (UNII: Q7AO2R1M0B)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    GLYCOL DISTEARATE (UNII: 13W7MDN21W)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    AMMONIUM XYLENESULFONATE (UNII: 4FZY6L6XCM)  
    COCO MONOETHANOLAMIDE (UNII: C80684146D)  
    GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE) (UNII: B16G315W7A)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    POLYQUATERNIUM-10 (400 CPS AT 2%) (UNII: HB1401PQFS)  
    POLYETHYLENE GLYCOL 7000 (UNII: Q0JET65GEL)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    CUCUMBER (UNII: YY7C30VXJT)  
    CYMBOPOGON SCHOENANTHUS LEAF (UNII: XF54B1Z2HF)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    SODIUM 2-NAPHTHALENESULFONATE (UNII: R5F0CTD2OJ)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59779-421-14400 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart358H02/17/2012
    Labeler - CVS PHARMACY (062312574)
    Registrant - APOLLO HEALTH AND BEAUTY CARE (201901209)
    Establishment
    NameAddressID/FEIBusiness Operations
    APOLLO HEALTH AND BEAUTY CARE201901209manufacture
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