AMMENS MEDICATED POWDER SHOWER FRESH- 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

Active ingredient

Zinc Oxide 5%

Purpose

Skin Protectant

Use

dries the oozing and weeping of poison:

• ivy

• oak

• sumac

Warnings

For external use only.

When using this product

• do not get into eyes

Stop use and ask 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

Inactive ingredients:

Zea Mays (Corn) Starch, Tricalcium Phosphate, Fragrance, Aloe Barbadensis Leaf Extract

Questions?

call to 1-800-487-7273

©IDELLE LABS, LTD.
All rights reserved.
Distributed by Idelle Labs,
Ltd., El Paso, TX 79912
Ammens® is a trademark
of Kaz Europe Sarl.


PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

AMMENS®

NEW 100% TALC FREE

TRUSTED FOR MORE THAN 100 YEARS

MEDICATED POWDER

SHOWER FRESH with ALOE

Soothes

Relieves

Absorbs

Net Wt 11oz (311g)

ammenspowderdrugpanel
AMMENS MEDICATED POWDER SHOWER FRESH 
zinc oxide powder
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41595-1061
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
STARCH, CORN (UNII: O8232NY3SJ)  
TRICALCIUM PHOSPHATE (UNII: K4C08XP666)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:41595-1061-1311 g in 1 CANISTER; Type 0: Not a Combination Product12/31/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34712/31/2017
Labeler - Idelle Labs, Ltd (128822926)
Establishment
NameAddressID/FEIBusiness Operations
M.K. Packaging, Inc.047022405manufacture(41595-1061)

Revised: 12/2017
Document Id: 213a3fb4-d15a-4a72-aa92-dee7fa228356
Set id: fc6db9f3-9059-40bb-84bf-69a3c0838bfa
Version: 1
Effective Time: 20171229
 
Idelle Labs, Ltd