Label: 2 IN 1 ANTIDANDRUFF- 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 March 30, 2017

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  • Active ingredient

    Pyrithione Zinc 1%

    Purpose

    Anti-dandruff

  • 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 use 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.

    If swallowed, get medical help or contact a Poison Control Center immediately.

  • Directions

    • For best results, use at least twice a week or as directed by a doctor.
    • For maximum dandruff control, use every time you shampoo.
    • Wet hair, massage onto scalp and rinse. Repeat if desired.
  • Other information

    Store at room temperature.

  • Inactive ingredients

    Water (Aqua), Sodium Laureth Sulfate, Sodium Chloride, Acrylates Copolymer, Glycol Distearate, Cocamidopropyl Betaine, Laureth-4, Dimethicone, Fragrance (Parfum), Cocamide MEA, Guar Hydroxypropyltrimonium Chloride, Sodium Hydroxide, Tetrasodium EDTA, Methylchloroisothiazolinone, Methylisothiazolinone, Blue 1 (CI 42090), Red 33 (CI 17200).

  • Label Copy

    Image of the label

  • INGREDIENTS AND APPEARANCE
    2 IN 1 ANTIDANDRUFF 
    pyrithione zinc shampoo
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63148-415
    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 LAURETH SULFATE (UNII: BPV390UAP0)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1) (UNII: 74G4R6TH13)  
    GLYCOL DISTEARATE (UNII: 13W7MDN21W)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    LAURETH-4 (UNII: 6HQ855798J)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    COCO MONOETHANOLAMIDE (UNII: C80684146D)  
    GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE) (UNII: B16G315W7A)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63148-415-14420 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/29/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart358H03/29/2017
    Labeler - Apollo Health and Beauty Care Inc. (201901209)
    Registrant - Apollo Health and Beauty Care Inc. (201901209)
    Establishment
    NameAddressID/FEIBusiness Operations
    Apollo Health and Beauty Care Inc.201901209manufacture(63148-415)
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