NDC Code(s) : 11084-089-35, 11084-089-39
Packager : Deb USA, Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

SBS Care Allantoin LOTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:11084-089
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Allantoin(UNII: 344S277G0Z)
(Allantoin - UNII:344S277G0Z) 		Allantoin0.5 mL in 100 mL
Inactive Ingredients
Ingredient Name Strength
Water(UNII: 059QF0KO0R)
Cetyl Esters Wax(UNII: D072FFP9GU)
Petrolatum(UNII: 4T6H12BN9U)
Isopropyl Palmitate(UNII: 8CRQ2TH63M)
Carbomer 934(UNII: Z135WT9208)
Trolamine(UNII: 9O3K93S3TK)
Chloroxylenol(UNII: 0F32U78V2Q)
Lanolin(UNII: 7EV65EAW6H)
Methylparaben(UNII: A2I8C7HI9T)
Jojoba Oil(UNII: 724GKU717M)
Wheat Germ Oil(UNII: 14C97E680P)
Aloe(UNII: V5VD430YW9)
Propylparaben(UNII: Z8IX2SC1OH)
Stearyl Alcohol(UNII: 2KR89I4H1Y)
Polyoxyl 20 Cetostearyl Ether(UNII: YRC528SWUY)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:11084-089-35150 mL in 1 TUBE
2NDC:11084-089-3930 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

PRINCIPAL DISPLAY PANEL

SBS Care

Medicated Skin Cream

Restore

1 fluid ounce

30 milliliters

Deb

89139-06-093

Proudly made in the USA by Deb

container label