HYVEE CARE CLASSIC CLEAN DANDRUFF (PYRITHIONE ZINC) SHAMPOO [HYVEE INC]

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HYVEE CARE CLASSIC CLEAN DANDRUFF (PYRITHIONE ZINC) SHAMPOO [HYVEE INC]
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NDC 42507-427-14
Set ID 891e43e7-45a3-486d-8015-12be49aa43c6
Category HUMAN OTC DRUG LABEL
Packager Hyvee Inc
Generic Name
Product Class
Product Number
Application Number PART358H
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  • Active ingredient

    Pyrithione Zinc 1%

    Purpose

    Anti-dandruff

  • Uses

    • helps to 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 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 Lauryl Sulfate, Sodium Laureth Sulfate, Glycol Distearate, Zinc Carbonate, Sodium Chloride, Sodium Xylenesulfonate, Dimethicone, Cocamidopropyl Betaine, Fragrance (Parfum), Sodium Benzoate, Guar Hydroxypropyltrimonium Chloride, Magnesium Carbonate Hydroxide, Methylchloroisothiazolinone, Methylisothiazolinone, Blue 1 (CI 42090), Red 33 (CI 17200).

  • Questions?

    Call 1-866-695-3030

  • Label Copy

    Image of the label

  • INGREDIENTS AND APPEARANCE
    HYVEE CARE CLASSIC CLEAN DANDRUFF 
    pyrithione zinc shampoo
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42507-427
    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)  
    SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
    GLYCOL DISTEARATE (UNII: 13W7MDN21W)  
    ZINC CARBONATE (UNII: EQR32Y7H0M)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SODIUM XYLENESULFONATE (UNII: G4LZF950UR)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE) (UNII: B16G315W7A)  
    MAGNESIUM CARBONATE HYDROXIDE (UNII: YQO029V1L4)  
    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:42507-427-14420 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/13/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart358H06/13/2016
    Labeler - Hyvee Inc (006925671)
    Registrant - Apollo Health and Beauty Care (201901209)
    Establishment
    NameAddressID/FEIBusiness Operations
    Apollo Health and Beauty Care201901209manufacture(42507-427)
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