STUDIO 35 MEDICATED BODY- menthol powder

Studio 35 Medicated Body by

Drug Labeling and Warnings

Studio 35 Medicated Body by is a Otc medication manufactured, distributed, or labeled by Walgreen Co, Vi-Jon, MK Packaging. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

Menthol 0.15%

purpose

External analgesic

Uses

for the temporary relief of pain and itching due to:

• minor cuts
• poison ivy
• scrapes
• sunburn
• poison oak
• minor burns
• insectd bites
• poison sumac
• minor skin irritations

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 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 area thoroughly before applying

inactive ingredients

talc, zinc oxide, acacia seyal gum, eucalyptol, methyl salicylate, salicylic acid, thymol, zinc stearate

Questions?

Call 1-800-925-4733

Disclaimer

This product is ot 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 Section

DISTRIBUTED BY: WALGREEN CO.

200 WILMOT RE., DEERFIELD, IL 60015

100% SATISFACTION GUARANTEED

MADE IN U.S.A. WITH U.S. AND FOREIGN COMPONENTS

379.000/379AA

Package Label. Principal Display Panel

COMPARE TO

GOLD BOND MEDICATED BODY POWDER

Studio 35

MEDICATED

BODY POWDER

EXTERNAL ANALGESIC

COOLING

ITCH RELEIF

ABSORBS MOISTURE

PLEASANTLY SCENTED WITH AN ESENTIAL OIL BLEND

NET WT 10 OZ (283 g)

INGREDIENTS AND APPEARANCE

STUDIO 35 MEDICATED BODY 
menthol powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0363-0043
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	1.5 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
TALC (UNII: 7SEV7J4R1U)
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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0363-0043-38	283 g in 1 BOTTLE; Type 0: Not a Combination Product	03/04/2014

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	03/04/2014

Labeler - Walgreen Co (008965063)

Registrant - Vi-Jon (790752542)

Establishment
Name	Address	ID/FEI	Business Operations
MK Packaging		047022405	manufacture(0363-0043)