MEDICATED BODY POWDER- menthol powder

Medicated Body Powder by

Drug Labeling and Warnings

Medicated Body Powder by is a Otc medication manufactured, distributed, or labeled by Meijer Distribution, Inc, Vi Jon. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients
Menthol 0.15%
Zinc oxide 1.0%

Purpose
External analgesic
Skin protectant

INDICATIONS & USAGE

Uses for the temporary relief of pain and itching due to:
minor cuts sunburn insect bites poison ivy
poison oak poison sumac scrapes minor burns
monor skin irritations
dries the oozing and weeping of:
poison ivy poison oak poison sumac

WARNINGS

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 form more than 7 days or clear up and occur again withing a few days

Keep out of reach of children.  If swallowed, get medical help or contact a Poison Control center right away.

DOSAGE & ADMINISTRATION

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

for best results dry skin thoroughly before applying

INACTIVE INGREDIENT

Inactive ingredients talc, acacia, eucalyptol, methyl salicylate, salicylic acid, thymol, zinc stearate

SPL UNCLASSIFIED SECTION

This product is not manufactured or distributed by Chattem, Inc.,
owner of the registered trademark Gold Bond.

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

ADVERSE REACTIONS

DIST. BY MEIJER DISTRIBUTION, INC.
2929 WALKER AVE NW
GRAND RAPIDS, MI 49544
www.meijer.com

PRINCIPAL DISPLAY PANEL

Meijer
MEDICATED
BODY POWDER
SKIN PROTECTANT
EXTERNAL ANALGESIC
COOLING ABSORBING
ITCH RELIEVING
COMPARE TO THE ACTIVE INGREDIENTS OF GOLD BOND
MEDICATED BODY POWDER
NET WT 10 OZ (283 g)

INGREDIENTS AND APPEARANCE

MEDICATED BODY POWDER 
menthol powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 41250-551
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	0.15 kg  in 100 kg
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	1.0 kg  in 100 kg

Inactive Ingredients
Ingredient Name	Strength
TALC (UNII: 7SEV7J4R1U)
ACACIA (UNII: 5C5403N26O)
EUCALYPTOL (UNII: RV6J6604TK)
METHYL SALICYLATE (UNII: LAV5U5022Y)
SALICYLIC ACID (UNII: O414PZ4LPZ)
THYMOL (UNII: 3J50XA376E)
ZINC STEARATE (UNII: H92E6QA4FV)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 41250-551-38	.283 kg in 1 BOTTLE, PUMP

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part348	05/05/2009

Labeler - Meijer Distribution, Inc (006959555)

Registrant - Vi Jon (790752542)

Establishment
Name	Address	ID/FEI	Business Operations
Vi Jon		790752542	manufacture