Label: SWEEN 24- dimethicone cream
- NDC Code(s): 11701-063-70, 11701-063-71, 11701-063-72, 11701-063-73
- Packager: Coloplast Manufacturing US, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated December 21, 2023
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- SPL UNCLASSIFIED SECTION
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- PRINCIPAL DISPLAY PANEL - 57 g Tube Label
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INGREDIENTS AND APPEARANCE
SWEEN 24
dimethicone creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:11701-063 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE 60 mg in 1 g Inactive Ingredients Ingredient Name Strength BEHENTRIMONIUM METHOSULFATE (UNII: 5SHP745C61) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) ETHYLHEXYL PALMITATE (UNII: 2865993309) GLYCERIN (UNII: PDC6A3C0OX) ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M) PEG-150 PENTAERYTHRITYL TETRASTEARATE (UNII: 8L4OOQ76AM) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:11701-063-71 142 g in 1 TUBE; Type 0: Not a Combination Product 06/15/2009 2 NDC:11701-063-70 256 g in 1 TUBE; Type 0: Not a Combination Product 06/15/2009 3 NDC:11701-063-73 57 g in 1 TUBE; Type 0: Not a Combination Product 06/15/2009 4 NDC:11701-063-72 4 g in 1 PACKET; Type 0: Not a Combination Product 06/15/2009 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M016 06/15/2009 Labeler - Coloplast Manufacturing US, LLC (110326675) Registrant - Coloplast Corp (847436391) Establishment Name Address ID/FEI Business Operations Coloplast Manufacturing US, LLC 110326675 MANUFACTURE(11701-063)