Body by Major Pharmaceuticals / Vi-Jon / MK Packaging BODY- menthol powder

Body by

Drug Labeling and Warnings

Body by is a Otc medication manufactured, distributed, or labeled by Major Pharmaceuticals, Vi-Jon, MK Packaging. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Menthol 0.15%

Purpose

External analgesic

Uses

for temporary relief of pan and itching due to:

• mnor cuts
• sunburn
• insect bites
• poison ivy
• poison oak
• poison sumac
• scrapes 
• minor burns
• minor skin irritations

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

• for best results dry skin thoroughly before applying

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)

INGREDIENTS AND APPEARANCE

BODY 
menthol powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0904-6348
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	1.5 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0904-6348-77	283 g in 1 BOTTLE; Type 0: Not a Combination Product	07/01/2013

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	07/01/2013

Labeler - Major Pharmaceuticals (191427277)

Registrant - Vi-Jon (790752542)

Establishment
Name	Address	ID/FEI	Business Operations
MK Packaging		047022405	manufacture(0904-6348)