STUDIO 35 EXTERNAL ANALGESIC MEDICATED BODY- menthol and zinc oxide powder 
Walgreen Co

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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Active Ingredients

Menthol         0.15%

Zinc Oxide     1.0%

Purpose

External analgesic

Skin protectant

Uses

for the temporary relief of pain and itching associated with:

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

Inactive Ingredients

zea mays (corn) starch, sodium bicarbonate,  tricalcium phosphate, acacia seyal gum, eucalyptol, methyl salicylate, salicylic acid, thymol, zinc stearate

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

Questions or comments?

Call 1-800-925-4733

DISTRIBUTED BY: WALGREEN CO.

200 WILMOT RE., DEERFIELD, IL 60015

100% SATISFACTION GUARANTEED

Principal Display Panel

Studio 35

EXTERNAL ANALGESIC

MEDICATED BODY POWDER

PAIN RELIEVING POWDER

DOES NOT CONTAIN TALC

COOLING

ITCH RELEIF

ABSORBS MOISTURE

NET WT 10 OZ (283 g)

label

STUDIO 35 EXTERNAL ANALGESIC MEDICATED BODY 
menthol and zinc oxide powder
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-0552
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL1.5 mg  in 1 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION10 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
STARCH, CORN (UNII: O8232NY3SJ)  
SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
TRICALCIUM PHOSPHATE (UNII: K4C08XP666)  
GUM TALHA (UNII: H18F76G097)  
EUCALYPTOL (UNII: RV6J6604TK)  
METHYL SALICYLATE (UNII: LAV5U5022Y)  
SALICYLIC ACID (UNII: O414PZ4LPZ)  
THYMOL (UNII: 3J50XA376E)  
ZINC STEARATE (UNII: H92E6QA4FV)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0363-0552-38283 g in 1 BOTTLE; Type 0: Not a Combination Product02/07/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34802/07/2017
Labeler - Walgreen Co (008965063)
Registrant - Jell Pharmaceuticals Pvt. Ltd. (726025211)
Establishment
NameAddressID/FEIBusiness Operations
Jell Pharmaceuticals Pvt. Ltd.726025211manufacture(0363-0552)

Revised: 2/2017
Document Id: 4807fb60-8d08-6e61-e054-00144ff8d46c
Set id: 2dd63063-45c1-4029-99ac-0962a27a5ddc
Version: 1
Effective Time: 20170208
 
Walgreen Co