Label: CONTROL ANTI-DANDRUFF- pyrithione zinc shampoo

  • NDC Code(s): 46324-2421-1, 46324-2421-2, 46324-2421-3, 46324-2421-8
  • Packager: AG Hair Ltd.
  • 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 June 15, 2023

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  • ACTIVE INGREDIENT:

    ZINC PYRIDINETHIONE (PYRITHIONE) 2%

    PURPOSE:

    Anti-Dandruff

  • USES:

    HELPS PREVENT RECURRENCE OF FLAKING AND ITCHING ASSOCIATED WITH DANDRUFF.

  • WARNING:

    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 THIS AND ALL DRUGS OUT OF REACH OF CHILDREN

    IF SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.

  • DIRECTIONS:

    • USE TWICE A WEEK, OR AS DIRECTED BY A PHYSICIAN FOR CHRONIC CONDITIONS.
    • MASSAGE INTO SCALP FOR 3-5 MINUTES. RINSE THOROUGHLY.
  • INACTIVE INGREDIENTS

    WATER (AQUA, EAU), AMMONIUM LAURETH SULFATE, COCAMIDOPROPYL BETAINE, PEG-4 RAPESEEDAMIDE, ALOE BARBADENSIS EXTRACT, CUCUMIS SATIVUS (CUCUMBER) FRUIT EXTRACT, ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER, SODIUM HYDROXIDE, PANTHENOL, HYDROLYZED KERATIN, SODIUM PCA, TOCOPHERYL ACETATE, SODIUM HYDROXYMETHYLGLYCINATE, CITRIC ACID, FRAGRANCE (PARFUM), ENTHOL, TETRASODIUM GLUTAMATE DIACETATE, PROPANEDIOL.

  • QUESTIONS (OR COMMENTS)?

    1-866-924-4247

  • PRODUCT LABELING

    Anti-Dandruff Shampoo2

  • INGREDIENTS AND APPEARANCE
    CONTROL ANTI-DANDRUFF 
    pyrithione zinc shampoo
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:46324-2421
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5) PYRITHIONE ZINC20 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    PEG-4 RAPESEEDAMIDE (UNII: 89575CN928)  
    ALOE (UNII: V5VD430YW9)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)  
    SODIUM HYDROXYMETHYLGLYCINATE (UNII: DIG6BWZ9XT)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    MENTHOL (UNII: L7T10EIP3A)  
    TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:46324-2421-8237 mL in 1 BOTTLE; Type 0: Not a Combination Product10/28/201106/30/2016
    2NDC:46324-2421-11000 mL in 1 BOTTLE; Type 0: Not a Combination Product10/28/201111/30/2015
    3NDC:46324-2421-2355 mL in 1 BOTTLE; Type 0: Not a Combination Product10/28/201110/14/2024
    4NDC:46324-2421-359 mL in 1 BOTTLE; Type 0: Not a Combination Product10/28/201110/28/2011
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart358H10/28/201110/31/2024
    Labeler - AG Hair Ltd. (203691886)
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