BODY- menthol powder
H-E-B

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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Foot Powder
865.001/864AB rev 1

Active ingredient

Menthol 1.0%

Purpose

External analgesic

Use

for the temporary relief of pain and itching associated with minor skin irritations on the foot

Warnings

For external use only

When using this product

do not get in to eyes

Stop use and ask a doctor

condition worsens
symptoms last 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

thoroughly was and dry feet, sprinkle powder liberally on feet, between toes and on bottoms of feet. For best results apply to affected areas up

to 3 or 4 times daily. Sprinkle inside shoes for added freshness.

Inactive ingredients

Zea mays (corn) starch, sodium bicarbonate, tricalcium phosphate, acacia seyal gum, benzethonium chloride, Eucalyptus globulus leaf oil, Mentha piperita (peppermint) oil

Disclaimer

This product is not manufactured or distributed by Chattem, Inc., distributor of Gold Bond Medicated Foot Powder Maximum Strength

This product is sold by weight, not by volume. Some settling may occur during handling and shipping.

DISTRIBUTED BY: H-E-B, SAN ANTONIO, TX 78204

LOT NUMBER: ON PACKAGE

QUESTIONS? 1-888-593-0593

If you aren't completel pleased with this product, we'll be happy to replace it or refund your money. You have our word on it.

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Compare to Gold Bond active ingredient

H-E-B

Medicated Foot Powder External analgesic

Controls odor
Absorbent
Itch Relieving

Net Wt 10 oz (283 g)

image description

BODY
menthol powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:37808-865
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	10 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
TALC (UNII: 7SEV7J4R1U)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)
TRICALCIUM PHOSPHATE (UNII: K4C08XP666)
GUM TALHA (UNII: H18F76G097)
BENZETHONIUM CHLORIDE (UNII: PH41D05744)
EUCALYPTUS OIL (UNII: 2R04ONI662)
PEPPERMINT OIL (UNII: AV092KU4JH)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:37808-865-38	283 g in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product	02/05/2015	12/09/2022

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	02/05/2015	12/09/2022

Labeler - H-E-B (007924756)

Registrant - Vi-Jon, LLC (790752542)

Name	Address	ID/FEI	Business Operations
Establishment
M&K Packaging		047022405	manufacture(37808-865)

Revised: 12/2022

Document Id: 02680b44-5175-45ff-bfb3-43dd983d01dc

Set id: c1c8a5a6-47c9-4636-a8d2-3cefc8bc67e1

Version: 9

Effective Time: 20221209