MEDICATED BODY- menthol and zinc oxide powder 
Universal Distribution Center LLC

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 Body Powder

Active Ingredients

Menthol         0.15%

Zinc Oxide     1.0%

Purpose

External analgesic

Skin protectant

Uses

for the temporary relief of pain and itching associated with:

Warnings

For external use only.

When using this product avoid contact with the eyes.

Stop use and ask a doctor if condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center  (1-800-222-1222) immediately.

Directions

Inactive Ingredients

Zea mays (corn) starch, sodium bicarbonate,  tricalcium phosphate, acacia seyal gum, eucalyptol, methyl salicylate, salicylic acid, thymol, zinc stearate

This product is sold by weight, not by volume. Some settling may occur during handling and shipping.

Principal Display Panel

Medicated Body Powder

NET WT. 10 oz (283 g)

label

MEDICATED BODY 
menthol and zinc oxide powder
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52000-038
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL1.5 mg  in 1 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION10 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
STARCH, CORN (UNII: O8232NY3SJ)  
SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
TRICALCIUM PHOSPHATE (UNII: K4C08XP666)  
GUM TALHA (UNII: H18F76G097)  
EUCALYPTOL (UNII: RV6J6604TK)  
METHYL SALICYLATE (UNII: LAV5U5022Y)  
SALICYLIC ACID (UNII: O414PZ4LPZ)  
THYMOL (UNII: 3J50XA376E)  
ZINC STEARATE (UNII: H92E6QA4FV)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52000-038-25283 g in 1 BOTTLE; Type 0: Not a Combination Product12/04/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34812/04/2017
Labeler - Universal Distribution Center LLC (019180459)
Registrant - Jell Pharmaceuticals Pvt. Ltd. (726025211)
Establishment
NameAddressID/FEIBusiness Operations
Jell Pharmaceuticals Pvt. Ltd.726025211manufacture(52000-038)

Revised: 12/2017
Document Id: 5f86e792-3255-4ee6-e053-2991aa0a54a0
Set id: 2a59a847-cc7a-42cf-b49a-92e7254c1629
Version: 1
Effective Time: 20171204
 
Universal Distribution Center LLC