Label: AMMENS MEDICATED POWDER SHOWER FRESH- 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 December 29, 2017

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  • Active ingredient

    Zinc Oxide 5%

  • Purpose

    Skin Protectant

  • Use

    dries the oozing and weeping of poison:

    • ivy

    • oak

    • sumac

  • Warnings

    For external use only.

  • When using this product

    • do not get into eyes

  • Stop use and ask doctor, if

    • condition worsens

    • symptoms last more than 7 days or clear up and occur again within a few days

  • Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    Apply as needed

  • Inactive ingredients:

    Zea Mays (Corn) Starch, Tricalcium Phosphate, Fragrance, Aloe Barbadensis Leaf Extract

  • Questions?

    call to 1-800-487-7273

    ©IDELLE LABS, LTD.
    All rights reserved.
    Distributed by Idelle Labs,
    Ltd., El Paso, TX 79912
    Ammens® is a trademark
    of Kaz Europe Sarl.


  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    AMMENS®

    NEW 100% TALC FREE

    TRUSTED FOR MORE THAN 100 YEARS

    MEDICATED POWDER

    SHOWER FRESH with ALOE

    Soothes

    Relieves

    Absorbs

    Net Wt 11oz (311g)

    ammenspowderdrugpanel
  • INGREDIENTS AND APPEARANCE
    AMMENS MEDICATED POWDER SHOWER FRESH 
    zinc oxide powder
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41595-1061
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    STARCH, CORN (UNII: O8232NY3SJ)  
    TRICALCIUM PHOSPHATE (UNII: K4C08XP666)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:41595-1061-1311 g in 1 CANISTER; Type 0: Not a Combination Product12/31/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34712/31/2017
    Labeler - Idelle Labs, Ltd (128822926)
    Establishment
    NameAddressID/FEIBusiness Operations
    M.K. Packaging, Inc.047022405manufacture(41595-1061)
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