Label: HEB DANDRUFF- pyrithione zinc 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 December 23, 2011

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  • ACTIVE INGREDIENT

    PYRITHIONE ZINC 1%

  • PURPOSE

    ANTI-DANDRUFF

  • USES

    HELPS PREVENT RECURRENCE OF FLAKING AND ITCHING ASSOCIATED WITH DANDRUFF

  • WARNINGS

    FOR EXTERNAL USE ONLY

    WHEN USING THIS PRODUCT

    AVOID CONTACT WITH EYES. IF CONTACT OCCURS, RINSE EYES THOROUGHLY WITH WATER.

    STOP USE AND ASK A DOCTOR IF

    CONDITION WORSONS OR DOES NOT IMPROVE AFTER REGULAR USE OF THIS PRODUCT AS DIRECTED

    KEEP OUT OF REACH OF CHILDREN

    IF SWALLOWED GET MEDICAL HELP OR CONTACT POISON CONTROL CENTER IMMEDIATELY

  • DIRECTIONS

    FOR MAXIMUM DANDRUFF CONTROL, USE EVERY TIME YOU SHAMPOO

    WET HAIR, MASSAGE ONTO SCALP, RINSE, REPEAT IF DESIRED

    FOR BEST RESULTS USE AT LEAST TWICE A WEEK OR AS DIRECTED  BY A DOCTOR

  • INACTIVE INGREDIENTS

    WATER, SODIUM LAURETH SULFATE, SODIUM LAURYL SULFATE, COCAMIDE DEA, ZINC CARBONATE, GLYCOL DISTEARATE, FRAGRANCE, DIMETHICONE, CETYL ALCOHOL, POLYQUATERNIUM-10, MAGNESIUM SULFATE, SODIUM BENZOATE, MENTHOL, PEG-7M, MAGNESIUM CARBONATE HYDROXIDE, AMMONIUM LAURETH SULFATE, SEA SALT, FUCUS  VESICULOSUS EXTRACT, BENZYL ALCOHOL, SODIUM CHLORIDE, METHYLCHLOROISOTHIAZOLINONE, METHYLISOTHIAZOLINONE,  SODIUM XYLENE SULFONATE, BLUE 1, YELLOW 5

  • LABEL COPY

    image of the label

  • INGREDIENTS AND APPEARANCE
    HEB  DANDRUFF
    pyrithione zinc shampoo
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37808-424
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5) PYRITHIONE ZINC1 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    COCO MONOETHANOLAMIDE (UNII: C80684146D)  
    ZINC CARBONATE (UNII: EQR32Y7H0M)  
    GLYCOL DISTEARATE (UNII: 13W7MDN21W)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    POLYQUATERNIUM-10 (400 CPS AT 2%) (UNII: HB1401PQFS)  
    MAGNESIUM SULFATE, UNSPECIFIED (UNII: DE08037SAB)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    MENTHOL (UNII: L7T10EIP3A)  
    POLYETHYLENE GLYCOL 7000 (UNII: Q0JET65GEL)  
    MAGNESIUM CARBONATE HYDROXIDE (UNII: YQO029V1L4)  
    AMMONIUM LAURETH-3 SULFATE (UNII: 896SJ235FN)  
    SEA SALT (UNII: 87GE52P74G)  
    FUCUS VESICULOSUS (UNII: 535G2ABX9M)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    SODIUM XYLENESULFONATE (UNII: G4LZF950UR)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:37808-424-14420 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart358H12/23/2011
    Labeler - HEB (007924756)
    Registrant - APOLLO HEALTH AND BEAUTY CARE (201901209)
    Establishment
    NameAddressID/FEIBusiness Operations
    APOLLO HEALTH AND BEAUTY CARE201901209manufacture
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