BODY- menthol powder
Exchange Select

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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Exchage Select 379.001/379AB

Active ingredient

Menthol 0.15%

Purpose

External analgesic

Uses

for temporary relief of pain and itching associated with:

minor burns
sunburn
minor cuts
scrapes
insects bites
minor skin irritations
rashes due to poinson 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 sold by weight, not by volume. Some settling may occur during handling and shipping

Adverse reactions

SATISFACTION GUARANTEED OR YOUR MONEY BACK

Manufactured For Your Military Exchanges

By: Vi-Jon

8515 Page Avenue

St. Louis, MO 63114

principal display panel

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MEDICATED

BODY POWDER

EXTERNAL ANALGESIC

ORIGINAL STRENGTH

Cooling

Itch Relief

TRIPLE BENEFITS

Absorbs

Moisture

quality

value

NET WT 10 OZ (283 g)

image description

BODY
menthol powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:55301-379
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:55301-379-38	283 g in 1 BOTTLE; Type 0: Not a Combination Product	11/30/2013	04/20/2021

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	11/30/2013	04/20/2021

Labeler - Exchange Select (001695568)

Registrant - Vi-Jon, LLC (790752542)

Name	Address	ID/FEI	Business Operations
Establishment
MK Packaging		047022405	manufacture(55301-379)

Revised: 4/2021

Document Id: 56f4387e-245e-4cf9-8013-4a076edc2e0b

Set id: fbd59237-6c24-440c-b31d-0c7632dba56f

Version: 7

Effective Time: 20210420

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