AMMENS MEDICATED POWDER ORIGINAL- zinc oxide powder

Ammens Medicated Powder Original by

Drug Labeling and Warnings

Ammens Medicated Powder Original by is a Otc medication manufactured, distributed, or labeled by Idelle Labs, Ltd, PTI Union, LLC, M.K. Packaging, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

label

INGREDIENTS AND APPEARANCE

AMMENS MEDICATED POWDER ORIGINAL 
zinc oxide powder

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

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

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

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

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

Labeler - Idelle Labs, Ltd (128822926)

Registrant - Idelle Labs, Ltd (128822926)

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

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