FDA Label for Studio35 Extra Strength Medicated Body

View Indications, Usage & Precautions

Studio35 Extra Strength Medicated Body Product Label

The following document was submitted to the FDA by the labeler of this product Walgreen Company. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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

* Please review the disclaimer below.