AMERFRESH MEDICATED- menthol and zinc oxide powder

Amerfresh Medicated by

Drug Labeling and Warnings

Amerfresh Medicated by is a Otc medication manufactured, distributed, or labeled by Amercare Products Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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Drug Facts

ACTIVE INGREDIENT

Active Ingredients	Purpose
Menthol 0.15%	Anti-itch
Zinc Oxide 1.0%	Skin Protection

Uses

temporarily relieves the pain and itch associated with:

• Minor cuts
• Sunburn
• Insect Bites
• Scrapes
• Prickly Heat
• Minor Burns
• Rashes
• Minor Skin Irritations
• Dries the oozing of poison ivy, oak and sumac.

Warnings

For external use only

• Avoid contact with eyes.

Stop use and ask a doctor if

• condition worsens
• symptoms do not get better within 7 days

Keep out of reach of children. In case of accidental ingestion, get medical help or contact a Poison Control right away.

Directions

adults and children 2 years and older	apply freely up to 3 or 4 times daily
Children under 2 years	ask a doctor
For best results dry skin thoroughly before applying

Inactive Ingredients

Talc, Eucalyptol, Methyl salicylate, Salicylic acid, Thymol, Zinc stearate.

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DISTRIBUTED BY
AMERCARE PRODUCTS, INC

PRINCIPAL DISPLAY PANEL - 283g Container Label

AMERFRESH®

BONDED
*FOR*
PURITY

MEDICATED

BODY

POWDER

NET WT.10 OZ. (283g)

INGREDIENTS AND APPEARANCE

AMERFRESH MEDICATED 
menthol and zinc oxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51460-0504
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Menthol (UNII: L7T10EIP3A) (Menthol - UNII:L7T10EIP3A)	Menthol	0.15 g  in 100 g
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	1 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
Talc (UNII: 7SEV7J4R1U)	97.4 g  in 100 g
Salicylic Acid (UNII: O414PZ4LPZ)
Methyl Salicylate (UNII: LAV5U5022Y)
Eucalyptol (UNII: RV6J6604TK)
Thymol (UNII: 3J50XA376E)
Zinc Stearate (UNII: H92E6QA4FV)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51460-0504-1	283 g in 1 CONTAINER

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	01/01/2005

Labeler - Amercare Products Inc (879289254)