AMMENS MEDICATED- zinc oxide powder
Botanicals Internacional S.A. de C.V.

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 - ORIGINAL MEDICATED FORMULA

DRUG FACTS

Active Ingredient Purpose

Zinc Oxide 9.1%...............................Skin Protectant

Purpose
Skin Protectant

Uses-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 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.

Do not use on broken skin.

When using this product, keep away from face and mouth to avoid breathing it in.

Directions

Apply as needed.

Other Information

Store at room temperature

Inactive Ingredients

corn starch, fragrance, isotearic acid, PPG-20 methyl glucose ether, talc

Questions or comments? 1-800-487-7273

Original Medicated Formula

Ammens(r) Since 1905. There's no better medicated powder at any price. Use after bath for deodorizing and lasting freshness.

Manufactured by:

Botanicals Internacional SA de CV

Av De la Luz #73 Parq. Ind. La Luz

Cuautitlan Izcalli

Edo. Mexico, 54716

Made in Mexico

Ammens is a registered trademark of Helen of Troy Lmited

Principal Display Panel

SKIN PROTECTANT

AMMENS

MEDICATED POWDER

ORIGINAL FORMULA

COOLS

SOOTHES

RELIEVES

DEODORIZES

Active Ingredient Zinc Oxide 9.1%

Net Wt. 11oz (312g)

Front

ammenspowderdrugpanel

AMMENS MEDICATED
zinc oxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:51384-100
Route of Administration	TOPICAL

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

Ingredient Name	Strength
Inactive Ingredients
ISOSTEARIC ACID (UNII: X33R8U0062)
STARCH, CORN (UNII: O8232NY3SJ)
TALC (UNII: 7SEV7J4R1U)
PPG-20 METHYL GLUCOSE ETHER (UNII: 3WV1T97D3K)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:51384-100-11	312 g in 1 BOTTLE; Type 0: Not a Combination Product	08/24/2010	01/02/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part347	07/29/2010	01/02/2020

Labeler - Botanicals Internacional S.A. de C.V. (823968961)

Name	Address	ID/FEI	Business Operations
Establishment
Botanicals Internacional S.A. de C.V.		823968961	manufacture(51384-100)

Revised: 9/2020

Document Id: aed111cf-3274-142d-e053-2995a90aa8c1

Set id: 2ea88746-d370-4ae3-a9e9-9609185f10c0

Version: 3

Effective Time: 20200908

Botanicals Internacional S.A. de C.V.