Label: MEDLINE- dimethicone cream
- NDC Code(s): 53329-159-04, 53329-159-13, 53329-159-77, 53329-159-96
- Packager: Medline Industries, LP
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated May 1, 2024
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- Active ingredient
- Purpose
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- Warnings
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Inactive ingredients
7-dehydrocholestrol, aphanizomenon flos-aquae (algae) extract, bisabolol, brassica campestris (rapeseed) sterols, camellia sinensis (green tea) leaf extract, caprylic/capric triglycerides, carthamus tinctorius (safflower) oleosomes, cetylhydroxyproline palmitamide, cholecalciferol, dimethicone crosspolymer, dimethiconol, divinyldimethicone/dimethicone copolymer emulsion, eugenia caryophyllus (clove) flower extract, glycerin, hexyldecanol, hydrolyzed soy protein, jojoba esters, lauryl PEG-10 tris (trimethylsiloxy) silylethyl dimethicone, manuka honey, olea europaea (olive) oil, PEG/PPG-18/18 dimethicone, phenoxyethanol, phospholipids, phytonadione, propanediol, purified water, sodium chloride, stearic acid, tocopheryl acetate, yeast ferment extract, zea mays (corn) oil.
- Manufacturing Information
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INGREDIENTS AND APPEARANCE
MEDLINE
dimethicone creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:53329-159 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE 125 mg in 1 mL Inactive Ingredients Ingredient Name Strength DIMETHICONOL (2000 CST) (UNII: T74O12AN6Y) JOJOBA OIL, RANDOMIZED (UNII: 7F0EV20QYL) PHENOXYETHANOL (UNII: HIE492ZZ3T) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) CHOLECALCIFEROL (UNII: 1C6V77QF41) CLOVE (UNII: K48IKT5321) HEXYLDECANOL (UNII: 151Z7P1317) HYDROLYZED SOY PROTEIN (ENZYMATIC; 2000 MW) (UNII: 1394NXB9L6) APHANIZOMENON FLOSAQUAE (UNII: 49VG1X560X) CARTHAMUS TINCTORIUS (SAFFLOWER) OLEOSOMES (UNII: 9S60Q72309) GLYCERIN (UNII: PDC6A3C0OX) OLIVE OIL (UNII: 6UYK2W1W1E) HONEY (UNII: Y9H1V576FH) CETYLHYDROXYPROLINE PALMITAMIDE (UNII: 74ONU0S62G) PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794) PHYTONADIONE (UNII: A034SE7857) PROPANEDIOL (UNII: 5965N8W85T) STEARIC ACID (UNII: 4ELV7Z65AP) ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) YEAST, UNSPECIFIED (UNII: 3NY3SM6B8U) CORN OIL (UNII: 8470G57WFM) WATER (UNII: 059QF0KO0R) SODIUM CHLORIDE (UNII: 451W47IQ8X) OMEGA-3 FATTY ACIDS (UNII: 71M78END5S) LEVOMENOL (UNII: 24WE03BX2T) RAPESEED STEROL (UNII: B46B6DD20U) GREEN TEA LEAF (UNII: W2ZU1RY8B0) 7-DEHYDROCHOLESTEROL (UNII: BK1IU07GKF) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:53329-159-13 59 mL in 1 TUBE; Type 0: Not a Combination Product 05/01/2023 2 NDC:53329-159-04 118 mL in 1 TUBE; Type 0: Not a Combination Product 04/01/2023 3 NDC:53329-159-77 4 mL in 1 PACKET; Type 0: Not a Combination Product 05/01/2024 4 NDC:53329-159-96 144 in 1 BOX 05/01/2024 4 4 mL in 1 PACKET; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M016 04/01/2023 Labeler - Medline Industries, LP (025460908) Registrant - Medline Industries, LP (025460908)