Label: BLADE HOWL ANTI-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 November 3, 2010

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  • Active Ingredient

    Pyrithione Zinc 1%

  • Purpose

    Antidandruff
  • Uses

    To help 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 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

    For maximum dandruff control, use every time you shampoo. Wet hair, massage onto scalp and rinse . Repeat if desired.

  • Inactive Ingredients

    Water (Aqua), Sodium Laureth Sulfate, Acrylates Copolymer, Polyquaternium-7, Cocamide MEA, Glycol Distearate, Cocamidopropyl Betaine, Fragrance (Parfum), Dimethicone, Sodium Chloride, Tetrasodium EDTA, Sodium Hydroxide, Citric Acid  DMDM Hydantoin, Blue 1 (CI 42090), Red 33 (CI 17200).
  • Package Front and Back Labels

    blade.jpg12 OZ Front and Bakc labels

  • INGREDIENTS AND APPEARANCE
    BLADE HOWL  ANTI-DANDRUFF
    pyrithione zinc shampoo
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59779-422
    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)  
    AMMONIO METHACRYLATE COPOLYMER TYPE A (UNII: 8GQS4E66YY)  
    POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600 KD) (UNII: 0L414VCS5Y)  
    COCO MONOETHANOLAMIDE (UNII: C80684146D)  
    GLYCOL DISTEARATE (UNII: 13W7MDN21W)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59779-422-12355 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart358H11/03/2010
    Labeler - CVS PHARMACY INC (062312574)
    Registrant - APOLLO HEALTH AND BEAUTY CARE (201901209)
    Establishment
    NameAddressID/FEIBusiness Operations
    APOLLO HEALTH AND BEAUTY CARE201901209manufacture
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