BODY- menthol powder 
Major Pharmaceuticals

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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Drug Facts

Active ingredient

Menthol 0.15%

Purpose

External analgesic

Uses

for temporary relief of pan and itching due to:

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 symtpoms 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 right away.

Directions

adults and children 2 years of age and older - apply to affected area not more than 3 to 4 times daily

children under 2 years of age - do not use, consult a doctor

Inactive ingredients

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

Questions

Call 1-800-616-2471

disclaimers

This product is not manufactured or distributed by Chattem, distributor of Gold Bond Medicated Body Powder.

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

Adverse Reaction

Distributed By 

MAJOR PHARMACEUTICALS

31778 ENTERPRISE DRIVE

LIVONIA, MI 48150  USA

Principal Display Panel

NDC 0904-6348-77

MAJOR

MEDICATED

BODY POWDER

Pain Relieving Powder

WITH ESSENTIAL OILS

Compare to Gold Bond Medicated

Body Powder

Soothes

Absorbs Moisture

Menthol 0.15 % Anti-Itch

NET WT 10 OZ (283 g)

image description

image description

BODY 
menthol powder
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0904-6348
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL1.5 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
STARCH, CORN (UNII: O8232NY3SJ)  
SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
TRICALCIUM PHOSPHATE (UNII: K4C08XP666)  
ZINC OXIDE (UNII: SOI2LOH54Z)  
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:0904-6348-77283 g in 1 BOTTLE; Type 0: Not a Combination Product07/01/2013
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34807/01/2013
Labeler - Major Pharmaceuticals (191427277)
Registrant - Vi-Jon (790752542)
Establishment
NameAddressID/FEIBusiness Operations
MK Packaging047022405manufacture(0904-6348)

Revised: 4/2018
Document Id: 3ca4b514-951f-4da7-bf5f-7ae1998e5b38
Set id: c0bd85ac-1114-4a02-b4a0-eb79fb935927
Version: 2
Effective Time: 20180413
 
Major Pharmaceuticals