MEDICATED BODY POWDER- menthol and zinc oxide powder 
MAGVERZ 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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Medicated Powder

Acitves

Menthol 0.15%
Zinc Oxide 1.0%

Inactives

Talc
Salicylic Acid
Methyl Salicylate
Eucalyptol
Thymol
Zinc Stearate

Acacia

Uses

Temporarily relieves the pain and itch associated with

Minor cuts

Purpose

Temporarily relieves the pain and itch

Directions

Warning

For external use only.

When using this product avoid contact with eyes.

Stop use and ask doctor if condition worsens, symptomos do not get better within 7 days.

Keep Out of Reach of Childrens

Keep out of reach of childrens.

Product Label

image Product Label

MEDICATED BODY POWDER 
menthol and zinc oxide powder
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59240-001
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)  
Salicylic Acid (UNII: O414PZ4LPZ)  
ACACIA (UNII: 5C5403N26O)  
EUCALYPTOL (UNII: RV6J6604TK)  
METHYL SALICYLATE (UNII: LAV5U5022Y)  
THYMOL (UNII: 3J50XA376E)  
ZINC STEARATE (UNII: H92E6QA4FV)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59240-001-01113 g in 1 CONTAINER
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34707/18/2013
Labeler - MAGVERZ INC (078712269)
Registrant - MAGVERZ INC (078712269)

Revised: 7/2013
Document Id: 6909f7f1-aff9-4bd6-83fc-d6acf4c8a0c0
Set id: 203ad2cc-f680-4f8f-a340-21c7b2ab8640
Version: 1
Effective Time: 20130715
 
MAGVERZ INC