Label: SBS 40- allantoin lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 11084-040-08, 11084-040-35, 11084-040-39 - Packager: Deb USA, Inc.
- Category: HUMAN OTC DRUG LABEL
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 3, 2010
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- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- DOSAGE & ADMINISTRATION
- INACTIVE INGREDIENT
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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
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INGREDIENTS AND APPEARANCE
SBS 40
allantoin lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:11084-040 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Allantoin (UNII: 344S277G0Z) (Allantoin - UNII:344S277G0Z) Allantoin 0.5 mL in 100 mL Inactive Ingredients Ingredient Name Strength Cetyl Esters Wax (UNII: D072FFP9GU) Petrolatum (UNII: 4T6H12BN9U) Isopropyl Palmitate (UNII: 8CRQ2TH63M) Carbomer 934 (UNII: Z135WT9208) Trolamine (UNII: 9O3K93S3TK) Chloroxylenol (UNII: 0F32U78V2Q) Methylparaben (UNII: A2I8C7HI9T) Lanolin (UNII: 7EV65EAW6H) Propylparaben (UNII: Z8IX2SC1OH) Stearyl Alcohol (UNII: 2KR89I4H1Y) POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY) METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN) METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA) MAGNESIUM NITRATE (UNII: 77CBG3UN78) MAGNESIUM CHLORIDE (UNII: 02F3473H9O) Water (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:11084-040-08 2500 mL in 1 BOTTLE, PLASTIC 2 NDC:11084-040-35 148 mL in 1 TUBE 3 NDC:11084-040-39 30 mL in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part347 01/01/2010 Labeler - Deb USA, Inc. (607378015) Establishment Name Address ID/FEI Business Operations Deb USA, Inc. 607378015 manufacture