Body by Topco Associates / Vi-Jon / MK Packaging BODY- menthol powder

Body by

Drug Labeling and Warnings

Body by is a Otc medication manufactured, distributed, or labeled by Topco Associates, 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 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 right away.

Directions

• adults and children 2 year 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

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 reactions

DISTRIBUTED BY TOPCO ASSOCIATES LLC

150 NORTHWEST POINT BLVD

ELK GROVE VILLAGE, IL 60007-1015

1-888-423-0139

topcare@topco.com

379.001/379AB

Principal Display Panel

Top Care

MEDICATED

body powder

external analgesic

relieves pain & itch

soothes

ABSORBS MOISTURE

COMPARE TO GOLD BOND

NET WT 10 OZ (283 g)

INGREDIENTS AND APPEARANCE

BODY 
menthol powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 36800-091
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: 36800-091-38	283 g in 1 BOTTLE; Type 0: Not a Combination Product	12/15/1987

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	12/15/1987

Labeler - Topco Associates (006935977)

Registrant - Vi-Jon (790752542)

Establishment
Name	Address	ID/FEI	Business Operations
MK Packaging		047022405	manufacture(36800-091)