Otc - Active Ingredient
Active Ingredient
Allantoin, 0.5%
Sbs 40
FDA Label NDC 11084-040
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 11084-040). 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 otc - active ingredient, otc - purpose, indications & usage, warnings, otc - when using, otc - stop use, otc - do not use, 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
Otc - Purpose
Purpose
Skin protectant
Indications & Usage
Uses
Temporarily protects and helps relieve chapped or cracked skin
Helps protect from the drying effects of wind and cold weather
Warnings
Warnings
For external use only
Otc - When Using
When using this product do not get in eyes
Otc - Stop Use
Stop use and ask a doctor if
conditions worsen
symptoms last more than 7 days
or clear up and occur again within a few days
Otc - Do Not Use
Enter section text here
Otc - Keep Out Of Reach Of Children
Keep out of the reach of children
Dosage & Administration
Directions
Apply SBS-40 as needed
Inactive Ingredient
Inactive Ingredients
Water, Cetyl Esters, Petrolatum, Isopropyl Palmitate, Stearyl Alcohol, Carbomer, Triethanolamine, Ceteareth-20, Chloroxylenol, Methylparaben, Lanolin, Propylparaben, Fragrance, Magnesium Nitrate, Methylchloroisothiazolinone, Magnesium Chloride, Methylisothiazolinone.
Package Label.Principal Display Panel
deb
SBS 40
Medicated Skin Cream
Skin Protectant
1-Protect
2-Cleanse
3-Restore
85 fl. oz. 2.5 liters
Made in U.S.A.
40108-05-026
Contains a blend of emollients including lanolin to keep skin soft and supple.
Recommended for professionals and individuals who have chapped or cracker hands.
Soothes and protects dry or chapped skin
* Please review the disclaimer below.
