AMMENS MEDICATED POWDER SHOWER FRESH FORMULA- 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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Ammens Medicated Powder Shower Fresh Formula

Medicated Powder
Ammens
Shower Fresh Formula

All-Day Protection


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


Warning:

For external use only.

When using this product

do not get into eyes.

Stop use and ask a doctor if

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:

Inactive Ingredients:

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

Questions or comments?

1-800-487-7273

©2004 Idelle Labs, Ltd. All rights reserved
Made in the USA and distributed by Idelle Labs, Ltd., El Paso, TX 79912

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label

AMMENS MEDICATED POWDER SHOWER FRESH FORMULA 
zinc oxide powder
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41595-1059
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)  
ISOSTEARIC ACID (UNII: X33R8U0062)  
TALC (UNII: 7SEV7J4R1U)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:41595-1059-2312 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(41595-1059)
Establishment
NameAddressID/FEIBusiness Operations
MK Packaging Inc.047022405MANUFACTURE(41595-1059)

Revised: 5/2013
Document Id: 04eebc94-3032-4757-be4d-875353c1d10a
Set id: 393eba67-1314-4495-83f5-438e91088aba
Version: 2
Effective Time: 20130521
 
Idelle Labs, Ltd