Active Ingredient
Allantoin, 0.5%
Sbs 40
FDA Label NDC 11084-240
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Deb Usa, Inc. for the product Sbs 40 (NDC 11084-240). 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, otc - 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
Purpose
Skin Protectant
Uses
Temporarily protects and helps relieve chapped or cracked skin
Helps protect from the drying effects of wind and cold weather
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.
In case of eye contact, flush with water.
Stop Use And Ask A Doctor If
irritation or sensitivity develops
condition worsens
symptoms last more than 7 days or clear up and occur again within a few days
Otc - Keep Out Of Reach Of Children
Keep out of reach of children
Directions
apply to clean, dry hands as needed
rub in well
Inactive Ingredients
Water, Cetyl Esters, Petrolatum, Isopropyl Palmitate, Phenoxyethanol, Stearyl Alcohol, Carbomer, Triethanolamine, Diazolidinyl Urea, Ceteareth-20, Lanolin, Fragrance
Package Label.Principal Display Panel
deb
SBS 40
Medicated Skin Cream
Silicone-free
Non-irritating
Non-greasy formulation
Helps heal dry hard-working hands
Industry's preferred brand for over 50 years
2.5 Liter
85 Fluid Ounces
USDA Certified Biobased Product
Made in USA
Deb USA, Inc.
Charlotte, NC 28217
1-800-248-7190
40108
Rev. 01-13
* Please review the disclaimer below.
