AMMENS MEDICATED POWDER ORIGINAL- zinc oxide powder 
Idelle Labs, Ltd

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.

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Medicated Powder
Ammens
Original Medicated Formula

All-Day Protection

  • soothes
  • deodorant protection
  • relieves chafing
  • cools

Active Ingredient Zinc Oxide 9.1%
MM1

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

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AMMENS MEDICATED POWDER ORIGINAL 
zinc oxide powder
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41595-1058
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (ZINC OXIDE) ZINC OXIDE9.1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
STARCH, CORN 
OXYQUINOLINE 
ISOSTEARIC ACID 
TALC 
Packaging
#Item CodePackage Description
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

Revised: 12/2010
Document Id: 5e7bbd98-0c4e-4b94-83ca-27d5fc97ef76
Set id: 8e264662-b5c8-4e64-a02b-c4f3e01564fb
Version: 3
Effective Time: 20101229
 
Idelle Labs, Ltd