Label: ANTI-DANDRUFF JUNIPER AND EUCALYPTUS- 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 15, 2019

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  • ACTIVE INGREDIENT

    Active ingredients Purpose

    Pyrithione Zinc 1% Anti-Dandruff

  • PURPOSE

    Use Help prevent reccurence of flaking and itching associated with dandruff

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. In case of accidental ingestion, get medical help or contact a Posion Control Center immediately.

  • INDICATIONS & USAGE

    Stop use and ask a doctor if condition worsens or does not improve after regular use of this product as directed.

  • WARNINGS

    Warnings

    · FOR EXTERNAL USE ONLY

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

  • DOSAGE & ADMINISTRATION

    Directions

    · For best results, use at least twice a week, or as directed by a doctor

    · Wet hair, massage onto scalp and rinse

    · repeat if desired

  • INACTIVE INGREDIENT

    Water(aqua, Eau), Sodium Laureth Sulfate, Disodium Cocoamphodiacetate, Acrylates Copolymer, Glycerin, Cocamidopropyl Betaine, Phenoxyethanol, Benzoic Acid, Ethylhexylglycerin, glycereth-2 Cocoate, Fragrance, Citric Acid.

  • PRINCIPAL DISPLAY PANEL

    Cremo

    Anti-Dandruff Shampoo

    Itch & Flake Relief Formula

    Moisturizes Hair and scalp while relieving dryness and itch

    Juniper & Eucalyptus

    16 fl oz 473 mL

    back

    front

  • INGREDIENTS AND APPEARANCE
    ANTI-DANDRUFF JUNIPER AND EUCALYPTUS 
    pyrithione zinc shampoo
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71825-105
    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)  
    DISODIUM COCOAMPHODIACETATE (UNII: 18L9G3U51M)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    BUTYL ACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID COPOLYMER (18000 MW) (UNII: JZ1374NL9E)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    GLYCERETH-2 COCOATE (UNII: JWM00VS7HC)  
    SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71825-105-01473 mL in 1 BOTTLE; Type 0: Not a Combination Product01/11/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart358H01/11/2019
    Labeler - Cremo company (078708508)
    Establishment
    NameAddressID/FEIBusiness Operations
    RNA PHARMA079103999manufacture(71825-105)
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