Label: AMMENS MEDICATED POWDER ORIGINAL- 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 14, 2013

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  • SPL UNCLASSIFIED SECTION

    Medicated Powder
    Ammens
    Original Medicated Formula

    All-Day Protection

    • soothes
    • deodorant protection
    • relieves chafing
    • cools


    Active Ingredient Zinc Oxide 9.1%

  • Active Ingredient:

    Zinc Oxide 9.1%

  • Purpose:

    Skin protectant powder


  • Uses:

    Dries the oozing and weeping of poison

    • ivy
    • oak
    • sumac

  • Warning:

    For external use only.

  • When using this product

    do not get into eyes.

  • Stop use and ask a 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.

  • Other Information:

    • Do not use on broken skin.
    • When using this product, keep away from face and mouth to avoid breathing it in.
  • Inactive Ingredients:

    Corn starch, fragrance, 8-hydroxyquinoline, 8-hydroxyquinoline sulfate, isostearic acid, PPG-20 methyl glucose ether, talc.

  • Questions or comments?

    1-800-487-7273

    ©2011 Idelle Labs, Ltd. All rights reserved
    Made in the USA and distributed by Idelle Labs, Ltd., El Paso, TX 79912

  • PRINCIPAL DISPLAY PANEL

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  • INGREDIENTS AND APPEARANCE
    AMMENS MEDICATED POWDER ORIGINAL 
    zinc oxide powder
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41595-1058
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION9.1 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    STARCH, CORN (UNII: O8232NY3SJ)  
    OXYQUINOLINE (UNII: 5UTX5635HP)  
    ISOSTEARIC ACID (UNII: X33R8U0062)  
    TALC (UNII: 7SEV7J4R1U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:41595-1058-1177 g in 1 CANISTER
    2NDC:41595-1058-2312 g in 1 CANISTER
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34702/01/2003
    Labeler - Idelle Labs, Ltd (128822926)
    Registrant - Idelle Labs, Ltd (128822926)
    Establishment
    NameAddressID/FEIBusiness Operations
    PTI Union, LLC807308858MANUFACTURE(41595-1058)
    Establishment
    NameAddressID/FEIBusiness Operations
    M.K. Packaging, Inc.047022405MANUFACTURE(41595-1058)
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