Label: STUDIO35 EXTRA STRENGTH MEDICATED BODY- dimethicone and menthol lotion

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

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.

Drug Label Information

Updated September 15, 2014

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  • 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

    Carton Label

  • INGREDIENTS AND APPEARANCE
    STUDIO35 EXTRA STRENGTH MEDICATED BODY 
    dimethicone and menthol lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-8410
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE5 g  in 100 mL
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL0.5 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    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 CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0363-8410-11396 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34709/01/2014
    Labeler - Walgreen Company (008965063)
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