Label: NATURAL 17 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 December 22, 2014

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  • DRUG FACTS

    Active Ingredient: Pyrithione Zinc 1%

    Purpose: Anti-dandruff

  • Use

    Helps prevent recurrence of flaking and itching associated with dandruff.

  • Warnings

    For external use only.

  • DOSAGE & ADMINISTRATION

    When using this product avoid contact with eyes. If contact occurs, rinse eyes thorougly 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 right away.

  • Directions

    • For maximum dandruff control, use every time you shampoo.
    • Wet hair, massage unto scalp, rinse, and repeat if desired.
    • For best results use at least twice a week or as directed by a doctor.
  • Inactive Ingredients:

    AQUA, SODIUM LAURYL ETHER SULFATE, COCAMIDOPROPYL BETAINE, COCAMIDOPROPYLAMINE OXIDE, COCOAMIDE DEA, ACRYLATES/ STEARETH-20 METHACRYLATE COPLOLYMER, PROPYLENE GLYCOL, DMDM HYDANTOIN, METHYLPARABEN, PROPYLPARABEN, PARFUM, POLYQUATERNIUM-7, CITRIC ACID, FD&C BLUE #1.

  • Manufactured by:

    Chemco Corp.

    Miami, FL 33014

  • Natural 17Anti-Dandruff

    Cleans & Refresh

    Suitable for all hair types

    recommended to combat dandruff fungus.

    8 fl. oz. (237 ml)

    Made in USA

    image description

  • INGREDIENTS AND APPEARANCE
    NATURAL 17 ANTI-DANDRUFF 
    pyrithione zinc shampoo
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49283-011
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5) PYRITHIONE ZINC1 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    COCAMIDOPROPYLAMINE OXIDE (UNII: M4SL82J7HK)  
    COCO DIETHANOLAMIDE (UNII: 92005F972D)  
    ETHYL ACRYLATE/METHACRYLIC ACID/STEARETH-20 METHACRYLATE COPOLYMER (UNII: EPA1872R1N)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600 KD) (UNII: 0L414VCS5Y)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49283-011-08237 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart358H08/08/2013
    Labeler - Chemco Corporation (032495954)
    Registrant - Chemco Corporation (032495954)
    Establishment
    NameAddressID/FEIBusiness Operations
    Chemco Corporation032495954manufacture(49283-011)
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