Label: DESIGN ESSENTIALS PEPPERMINT - ALOE THERAPEUTICS- 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 January 20, 2016

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  • ACTIVE INGREDIENT

    Active Ingredients:

    Pyrithione Zinc 1%

  • PURPOSE

    Purpose: Antidandruff

  • INDICATIONS & USAGE

    Use: controls flaking, itching and irritation associated with dandruff and seborrheic dermatitis

  • WARNINGS

    Warnings:

    • For external use only.
  • WHEN USING

    When using this product Avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water.

  • ASK DOCTOR

    Consult your physician before using this product if condition covers a large area of the body.

  • STOP USE

    Stop use and consult a physician if condition worsens or does not improve after regular use.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical help or contact Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    Directions

    • For best results use at least twice a week or as directed by a physician.

    • Wet hair, lather and massage gently into the hair and scalp.

    • Rinse thoroughly and repeat if necessary.

  • INACTIVE INGREDIENT

    Inactive Ingredients

    Water (Aqua), Sodium Lauryl Sulfate, Cocamidopropyl Betaine, Cocamidopropylamine Oxide, Propylene Glycol, Menthol, Mentha Piperita(Peppermint) Oil, Phenoxyethanol (and) DMDM Hydantoin (and) Iodopropnyl Butylcarbamate, Montmorillonite, Aloe Barbadensis (Aloe) Leaf Juice, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Guar Hydroxypropyltrimonium Chloride, Sodium Chloride, Citric Acid, FD& C Blue #1 (C.I. 420090), FD&C Red #33 (C.I. 17200), FD&C Yellow No.5 (C.I. 19140).

  • PRINCIPAL DISPLAY PANEL


    Mcbride Shampoo 8 oz

    Mcbride Shampoo 32 oz

  • INGREDIENTS AND APPEARANCE
    DESIGN ESSENTIALS PEPPERMINT - ALOE THERAPEUTICS 
    pyrithione zinc shampoo
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69527-122
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5) PYRITHIONE ZINC10 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    COCAMIDOPROPYLAMINE OXIDE (UNII: M4SL82J7HK)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    MENTHOL (UNII: L7T10EIP3A)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
    MONTMORILLONITE (UNII: A585MN1H2L)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE) (UNII: B16G315W7A)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69527-122-08237 mL in 1 BOTTLE; Type 0: Not a Combination Product01/14/2012
    2NDC:69527-122-32947 mL in 1 BOTTLE; Type 0: Not a Combination Product01/14/2012
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart358H01/14/2012
    Labeler - .McBride Research Laboratories, Inc. (783701287)
    Establishment
    NameAddressID/FEIBusiness Operations
    RNA PHARMA, LLC079103999manufacture(69527-122)
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