Studio35 Extra Strength Medicated Body
FDA Label NDC 0363-8410

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Walgreen Company for the product Studio35 Extra Strength Medicated Body (NDC 0363-8410). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient, purpose, uses, warnings, do not use on, when using this product, stop use and ask a doctor if, keep out of reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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 (Image 01)

Carton Label (Image 01)

Carton Label

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