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Medicated Body by Universal Distribution Center LLC

Medically reviewed on Nov 3, 2017

Dosage form: powder
Ingredients: MENTHOL 0.15g in 100g, ZINC OXIDE 1g in 100g
Labeler: Universal Distribution Center LLC
NDC Code: 52000-024

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.

Medicated Body Powder

Active Ingredients

Menthol        0.15%

Zinc Oxide      1.0%

Purpose

Anti-itch

Uses

For the temporary relief from pain and itching associated with minor cuts and burns, sunburn, scrapes, insect bites, and other minor skin irritation. Also for drying up poison oak, which helps control the growth of fungi associated with athlete's foot and jock itch.

Warning

For external use only.

Avoid contact with eyes.

If symptoms persist more than 7 days, worsen with use or return within a few days of cleaning up, discontinue use of this product and consult a doctor.

Keep out of reach of children

In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.

Directions

Use after shower, bath or exercise. Use in footwear and on feet. Dry skin completely before applying. For adults and children over 2 years; apply to affected area not more than 3 or 4 times daily. Children Under 2 Years; Consult a doctor.

Inactive Ingredients

talc, acacia, eucalyptus oil, methyl salicylate, salicylic acid, thymol, zinc stearate.

PRINCIPAL DISPLAY PANEL

MEDICATED BODY POWDER

NET WT. 10 OZ. (283g)

MEDICATED BODY 
menthol and zinc oxide powder
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52000-024
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 
ACACIA 
EUCALYPTUS OIL 
METHYL SALICYLATE 
SALICYLIC ACID 
THYMOL 
ZINC STEARATE 
Packaging
#Item CodePackage Description
1NDC:52000-024-25283 g in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34811/03/2015
Labeler - Universal Distribution Center LLC (019180459)
Registrant - Jell Pharmaceuticals Pvt. Ltd. (726025211)
Establishment
NameAddressID/FEIOperations
Jell Pharmaceuticals Pvt. Ltd.726025211manufacture(52000-024)

 
Universal Distribution Center LLC

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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