AMERFRESH MEDICATED- menthol and zinc oxide powder 
Amercare Products Inc

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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AMERFRESH®
MEDICATED
BODY
POWDER

Drug Facts

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

Uses

temporarily relieves the pain and itch associated with:

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 olderapply freely up to 3 or 4 times daily
Children under 2 yearsask a doctor
For best results dry skin thoroughly before applying

Inactive Ingredients

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

DISTRIBUTED BY
AMERCARE PRODUCTS, INC

PRINCIPAL DISPLAY PANEL - 283g Container Label

AMERFRESH®

BONDED
*FOR*
PURITY

MEDICATED

BODY

POWDER

NET WT.10 OZ. (283g)

PRINCIPAL DISPLAY PANEL - 283g Container Label
AMERFRESH MEDICATED 
menthol and zinc oxide powder
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51460-0504
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Menthol (UNII: L7T10EIP3A) (Menthol - UNII:L7T10EIP3A) Menthol0.15 g  in 100 g
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51460-0504-1283 g in 1 CONTAINER
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34701/01/2005
Labeler - Amercare Products Inc (879289254)

Revised: 5/2011
Document Id: 01111ea5-3692-4b9a-889f-6619fb056913
Set id: fded3bee-45e8-47e1-8292-b15983654788
Version: 1
Effective Time: 20110512
 
Amercare Products Inc