AMMENS MEDICATED- zinc oxide powder

AMMENS MEDICATED by

Drug Labeling and Warnings

AMMENS MEDICATED by is a Otc medication manufactured, distributed, or labeled by Botanicals Internacional S.A. de C.V.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

DRUG FACTS

Active Ingredient                              Purpose

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

PURPOSE

Purpose
Skin Protectant

INDICATIONS & USAGE

Uses-dries the oozing and weeping of poison

ivy

oak

sumac

WARNINGS

Warnings

for external use only

WHEN USING

When using this product do not get into eyes.

STOP USE

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

Keep out of reach of children. if swallowed, get medical help or contact a Poison Control Center right away.

DO NOT USE

Do not use on broken skin.

WHEN USING

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

DOSAGE & ADMINISTRATION

Directions

Apply as needed.

SPL UNCLASSIFIED SECTION

Other Information

Store at room temperature

INACTIVE INGREDIENT

Inactive Ingredients

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

QUESTIONS

Questions or comments? 1-800-487-7273

SPL UNCLASSIFIED SECTION

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)

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

AMMENS MEDICATED 
zinc oxide powder

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

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

Inactive Ingredients
Ingredient Name	Strength
TALC (UNII: 7SEV7J4R1U)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51384-100-11	312 g in 1 BOTTLE

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

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

Establishment
Name	Address	ID/FEI	Business Operations
Botanicals Internacional S.A. de C.V.		823968961	manufacture