Your browser does not support JavaScript! MEDICATED BODY POWDER (MENTHOL AND ZINC OXIDE) POWDER [MAGVERZ INC]
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MEDICATED BODY POWDER (menthol and zinc oxide) powder
[MAGVERZ INC]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph final
NOTE: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.
Drug Label Sections

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

  • Sunburn Insect Bites
  • Scrapes Prickly
  • HeatMinor
  • Burns Rashes
  • Minor Skin Irritations

Purpose

Temporarily relieves the pain and itch

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.

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 DRUG LABELItem Code (Source)NDC:59240-001
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (MENTHOL) MENTHOL0.15 g  in 100 g
ZINC OXIDE (ZINC OXIDE) ZINC OXIDE1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
TALC 
Salicylic Acid 
ACACIA 
EUCALYPTOL 
METHYL SALICYLATE 
THYMOL 
ZINC STEARATE 
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
 
MAGVERZ INC

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