Label: AMERFRESH MEDICATED- menthol and zinc oxide powder

  • 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 May 12, 2011

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active IngredientsPurpose
    Menthol 0.15%Anti-itch
    Zinc Oxide 1.0%Skin Protection
  • Uses

    temporarily relieves the pain and itch associated with:

    • Minor cuts
    • Sunburn
    • Insect Bites
    • Scrapes
    • Prickly Heat
    • Minor Burns
    • Rashes
    • Minor Skin Irritations
    • Dries the oozing of poison ivy, oak and sumac.
  • Warnings

    For external use only

    • Avoid contact with eyes.

    Stop use and ask a doctor if

    • condition worsens
    • symptoms do not get better within 7 days

    Keep out of reach of children. In case of accidental ingestion, get medical help or contact a Poison Control right away.

  • Directions

    adults and children 2 years and olderapply freely up to 3 or 4 times daily
    Children under 2 yearsask a doctor
    For best results dry skin thoroughly before applying
  • Inactive Ingredients

    Talc, Eucalyptol, Methyl salicylate, Salicylic acid, Thymol, Zinc stearate.

  • SPL UNCLASSIFIED SECTION

    DISTRIBUTED BY
    AMERCARE PRODUCTS, INC

  • PRINCIPAL DISPLAY PANEL - 283g Container Label

    AMERFRESH®

    BONDED
    *FOR*
    PURITY

    MEDICATED

    BODY

    POWDER

    NET WT.10 OZ. (283g)

    PRINCIPAL DISPLAY PANEL - 283g Container Label
  • INGREDIENTS AND APPEARANCE
    AMERFRESH MEDICATED 
    menthol and zinc oxide powder
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51460-0504
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Menthol (UNII: L7T10EIP3A) (Menthol - UNII:L7T10EIP3A) Menthol0.15 g  in 100 g
    Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide1 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    Talc (UNII: 7SEV7J4R1U) 97.4 g  in 100 g
    Salicylic Acid (UNII: O414PZ4LPZ)  
    Methyl Salicylate (UNII: LAV5U5022Y)  
    Eucalyptol (UNII: RV6J6604TK)  
    Thymol (UNII: 3J50XA376E)  
    Zinc Stearate (UNII: H92E6QA4FV)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51460-0504-1283 g in 1 CONTAINER
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34701/01/2005
    Labeler - Amercare Products Inc (879289254)
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