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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Ammens Medicated Powder

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

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label

AMMENS MEDICATED POWDER ORIGINAL
zinc oxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:41595-1058
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	9.1 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
STARCH, CORN (UNII: O8232NY3SJ)
OXYQUINOLINE (UNII: 5UTX5635HP)
ISOSTEARIC ACID (UNII: X33R8U0062)
TALC (UNII: 7SEV7J4R1U)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:41595-1058-1	177 g in 1 CANISTER
2	NDC:41595-1058-2	312 g in 1 CANISTER

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part347	02/01/2003

Labeler - Idelle Labs, Ltd (128822926)

Registrant - Idelle Labs, Ltd (128822926)

Name	Address	ID/FEI	Business Operations
Establishment
PTI Union, LLC		807308858	MANUFACTURE(41595-1058)

Name	Address	ID/FEI	Business Operations
Establishment
M.K. Packaging, Inc.		047022405	MANUFACTURE(41595-1058)

Revised: 5/2013

Document Id: 6ec59bf1-1ccd-4428-a013-f42954521a9e

Set id: 8e264662-b5c8-4e64-a02b-c4f3e01564fb

Version: 4

Effective Time: 20130514

Idelle Labs, Ltd