MEDICATED BODY POWDER- menthol powder 
Jell Pharmaceuticals Pvt Ltd

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

Drug Facts

Active Ingredients

Menthol 0.15 %

Purpose

External Analgesic

Uses

for the temporary relief of the pain and itch associated with

Warnings

For external use only

When usin this product

Avoid contact with eyes. Not for genital area.

Stop use and ask a doctor if

Keep out of reach of children

Keep out of reach of children. In case of accidental ingestion, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

Inactive Ingredients

acacia seyl gum, eucalyptol, methyl salicylate, salicylic acid, sodium bicarbonate, thymol, tricalciun phosphate, zea mays (corn stach), zinc oxide, zinc stearate

Equate Medicated Body Powder Original

Label

MEDICATED BODY  POWDER
menthol powder
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:30400-506
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL0.42 g  in 283 g
Inactive Ingredients
Ingredient NameStrength
SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
TRICALCIUM PHOSPHATE (UNII: K4C08XP666)  
ACACIA (UNII: 5C5403N26O)  
EUCALYPTUS OIL (UNII: 2R04ONI662)  
MENTHYL SALICYLATE, (+/-)- (UNII: 43XOA705ZD)  
SALICYLIC ACID (UNII: O414PZ4LPZ)  
THYMOL (UNII: 3J50XA376E)  
ZINC STEARATE (UNII: H92E6QA4FV)  
ZINC OXIDE (UNII: SOI2LOH54Z)  
ZEA MAYS WHOLE (UNII: 1G5HNE09V8)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:30400-506-01283 g in 1 BOTTLE; Type 0: Not a Combination Product09/01/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34809/01/2020
Labeler - Jell Pharmaceuticals Pvt Ltd (726025211)
Registrant - Jell Pharmaceuticals pvt ltd (726025211)
Establishment
NameAddressID/FEIBusiness Operations
Jell Pharmaceuticals Pvt Ltd.726025211manufacture(30400-506)

Revised: 10/2021
Document Id: cdaaf8cd-1bcd-bf8c-e053-2a95a90af887
Set id: cdaaf8cd-1bcc-bf8c-e053-2a95a90af887
Version: 1
Effective Time: 20211005
 
Jell Pharmaceuticals Pvt Ltd