BODY- menthol powder
Topco Associates

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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Top Care 379.001 379AB

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

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)

image description

BODY
menthol powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:36800-091
Route of Administration	TOPICAL

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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:36800-091-38	283 g in 1 BOTTLE; Type 0: Not a Combination Product	12/15/1987	04/27/2022

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	12/15/1987	04/27/2022

Labeler - Topco Associates (006935977)

Registrant - Vi-Jon, LLC (790752542)

Name	Address	ID/FEI	Business Operations
Establishment
Vi-Jon, LLC		790752542	manufacture(36800-091)

Revised: 4/2022

Document Id: df37ebae-2d3e-4e8f-b363-a838f9a85b79

Set id: 9e4b3f77-07a9-4190-8722-4749ac1c2d39

Version: 9

Effective Time: 20220427

Topco Associates