body by H-E-B / Vi-Jon / M&K Packaging BODY- menthol powder

body by

Drug Labeling and Warnings

body by is a Otc medication manufactured, distributed, or labeled by H-E-B, Vi-Jon, M&K Packaging. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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.

advese reactions

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.

865.001/865AB

princpal display panel

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)

INGREDIENTS AND APPEARANCE

BODY 
menthol powder

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

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

Inactive Ingredients
Ingredient Name	Strength
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)

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

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

Labeler - H-E-B (007924756)

Registrant - Vi-Jon (790752542)

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