BODY- menthol, zinc oxide powder
Vi-Jon, LLC

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.

----------

Swan 379.001-379AB

Active ingredient

Menthol 0.15%

Purpose

External analgesic

Uses

for temporary relief of pain and itching associated with:

minor cuts
sunburn
insect bites
scrapes
minor burns
minor skin irritatios
rashes due to poison ivy, poison oak, poison sumac

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:

Vi-Jon

8515 Page Ave. St. Louis, MO 63114

principal display panel

NDC 11344-379-38

Swan

MEDICATED

BODY

POWDER

EXTERNAL ANALGESIC

COOLING
ABSORBENT
ITCH RELIEF

Compare to Gold Bond

NET WT 10 OZ (283 g)

image description

BODY
menthol, zinc oxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:11344-379
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:11344-379-38	283 g in 1 BOTTLE; Type 0: Not a Combination Product	10/21/1992	04/27/2022

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	10/21/1992	04/27/2022

Labeler - Vi-Jon, LLC (790752542)

Registrant - Vi-Jon, LLC (790752542)

Name	Address	ID/FEI	Business Operations
Establishment
MK Packaging		047022405	manufacture(11344-379)

Revised: 4/2022

Document Id: 79952f4b-b9f2-47c0-b398-0beaf9341860

Set id: 112867fc-cdc5-43d2-9f38-64bd8de8346e

Version: 8

Effective Time: 20220427

Vi-Jon, LLC