Label: SBS 40 MEDICATED CREAM- allantoin cream
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- NDC Code(s): 11084-241-08, 11084-241-10, 11084-241-35, 11084-241-39
- Packager: SC Johnson Professional USA, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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 December 2, 2020
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- Active ingredient
- Purpose
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- Inactive ingredients
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PRINCIPAL DISPLAY PANEL
deb stoko
SBS-40
Medicated Skin Cream
Normal Skin
Crema medicada para la piel
Piel normal
EN Skin conditioning cream. Ideal for irritated skin.
Non-greasy. Non-irritating.
ES Acondicionador para la piel. Ideal para la piel
irritada. No es grasiento. No es irritante.
100 ml (3.38 fl oz)
Stock #:
SBS100ML
DCN8807/0115
Deb USA, Inc.
Charlotte, NC 28217
1-800-248-7190
www.debgroup.com Made in USA
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INGREDIENTS AND APPEARANCE
SBS 40 MEDICATED CREAM
allantoin creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:11084-241 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALLANTOIN (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z) ALLANTOIN 5 mg in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) CETYL ESTERS WAX (UNII: D072FFP9GU) PETROLATUM (UNII: 4T6H12BN9U) ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M) STEARYL ALCOHOL (UNII: 2KR89I4H1Y) CARBOMER 934 (UNII: Z135WT9208) POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY) CHLOROXYLENOL (UNII: 0F32U78V2Q) METHYLPARABEN (UNII: A2I8C7HI9T) LANOLIN (UNII: 7EV65EAW6H) SODIUM HYDROXIDE (UNII: 55X04QC32I) PROPYLPARABEN (UNII: Z8IX2SC1OH) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:11084-241-08 2500 mL in 1 BOTTLE; Type 0: Not a Combination Product 12/01/2013 06/30/2021 2 NDC:11084-241-35 148 mL in 1 TUBE; Type 0: Not a Combination Product 12/01/2013 04/01/2018 3 NDC:11084-241-39 30 mL in 1 TUBE; Type 0: Not a Combination Product 12/01/2013 01/28/2023 4 NDC:11084-241-10 100 mL in 1 TUBE; Type 0: Not a Combination Product 06/01/2015 02/03/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part347 11/01/2013 12/31/2023 Labeler - SC Johnson Professional USA, Inc. (607378015) Establishment Name Address ID/FEI Business Operations SC Johnson Professional USA, Inc. 078805627 manufacture(11084-241)