STUDIO35 EXTRA STRENGTH MEDICATED BODY- dimethicone and menthol lotion

Studio35 Extra Strength Medicated Body by

Drug Labeling and Warnings

Studio35 Extra Strength Medicated Body by is a Otc medication manufactured, distributed, or labeled by Walgreen Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Dimethicone, 5.0%

Menthol, 0.5%

Purpose

Skin Protectant

Anti-Itch

Uses

• temporarily relieves itching associated with
  • sunburn
  • minor skin irritation
  • minor burns
  • rashes due to poison ivy, oak or sumac
  • insect bites
• temporarily protects and helps relieve chapped or cracked skin

Warnings

For external use only.

Do Not Use On

• deep or puncture wounds
• animal bites
• serious burns

When using this product

• avoid contact with eyes

Stop use and ask a doctor if

• condition worsens
• symptoms persist for more than 7 days or clear up and occur again within a few days
• redness, irritation, swelling or pain persists or increases

Keep Out of Reach of Children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

For adults and children 2 years and older: Apply liberally 3 to 4 times daily to affected area. Children under 2 years: consult with a doctor.

Inactive ingredients

water, cetyl alcohol, glycerin, stearamidopropyl PG-dimonium chloride phosphate, stearyl alcohol, cetearyl alcohol, ceteareth-20, distearyldimonium chloride, petrolatum, steareth-21, propylene glycol, diazolidinyl urea, methylparaben, propylparaben, steareth-2, aloe barbadensis leaf juice, tocopheryl acetate (vitamin E), butylene glycol, pentylene glycol, hydroxyphenyl propamidobenzoic acid, xylitylglucoside, anhydroxylitol, xylitol, disodium EDTA, fragrance, triethanolamine.

Questions or comments?

1-800-925-4733

Package/Label Principal Display Panel

COMPARE TO GOLD
BOND® EXTRA STRENGTH
MEDICATED BODY LOTION*

studio35™

EXTRA STRENGTH
MEDICATED
BODY LOTION

WITH ALOE AND VITAMIN E

ENRICHED WITH SYMCALMIN®
TO SOOTHE

MOISTURIZES & COOLS
SEVERELY DRY, IRRITATED SKIN

ANTI-ITCH/SKIN PROTECTANT

NET WT 14 OZ (396 g)

EXTRA STRENGTH
MEDICATED BODY LOTION

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

DISTRIBUTED BY: WALGREEN CO.
200 WILMOT RD. DEERFIELD, IL 60015
100% SATISFACTION GUARANTEED
walgreens.com ©2014 Walgreen Co.
MADE IN ISRAEL

Carton Label

INGREDIENTS AND APPEARANCE

STUDIO35 EXTRA STRENGTH MEDICATED BODY 
dimethicone and menthol lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0363-8410
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	5 g  in 100 mL
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	0.5 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CETYL ALCOHOL (UNII: 936JST6JCN)
GLYCERIN (UNII: PDC6A3C0OX)
STEARAMIDOPROPYL PROPYLENE GLYCOL-DIMONIUM CHLORIDE PHOSPHATE (UNII: W6000VEI5Y)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)
DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X)
PETROLATUM (UNII: 4T6H12BN9U)
STEARETH-21 (UNII: 53J3F32P58)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
STEARETH-2 (UNII: V56DFE46J5)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
HYDROXYPHENYL PROPAMIDOBENZOIC ACID (UNII: 25KRT26H77)
XYLITYLGLUCOSIDE (UNII: O0IEZ166FB)
ANHYDROXYLITOL (UNII: 8XWR7NN42F)
XYLITOL (UNII: VCQ006KQ1E)
EDETATE DISODIUM (UNII: 7FLD91C86K)
TROLAMINE (UNII: 9O3K93S3TK)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0363-8410-11	396 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	09/01/2014

Labeler - Walgreen Company (008965063)