Label: DIMETHICONE- skin protectant cream
- NDC Code(s): 68599-0218-1, 68599-0218-4, 68599-0218-8
- Packager: McKesson
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated June 18, 2024
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- OTHER SAFETY INFORMATION
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INACTIVE INGREDIENT
Inactive ingredients
Alanine, Aleurites Moluccanus (Kukui) Seed Oil, Aloe
Barbadensis Leaf Juice, Arginine, Aspartic Acid, Bisabolol,
Butylene Glycol, Calcium Pantothenate (Vitamin B5), Caprylyl
Glycol, Carthamus Tinctorius (Safflower) Oleosomes,
Carthamus Tinctorius (Safflower) Seed Oil, Cetyl Alcohol,
Chlorphenesin, Dimethicone Crosspolymer, Dimethicone,
Disodium EDTA, Fragrance, Glutamic Acid, Glycerin, Glyceryl
Stearate, Glycine, Histidine, Isoleucine, Leucine, Lysine,
Maltodextrin, Niacinamide (Vitamin B3), PEG-100 Stearate,
Phenoxyethanol, Phenylalanine, Proline, Pyridoxine HCl
(Vitamin B6), Serine, Silica, Sodium Ascorbyl Phosphate
(Vitamin C), Sodium Hyaluronate, Sodium Starch
Octenylsuccinate, Stearic Acid, Threonine, Tocopheryl Acetate
(Vitamin E), Triethanolamine, Tyrosine, Valine, Water, Zingiber
Officinale (Ginger) Root Extract - QUESTIONS
- PRINCIPAL DISPLAY PANEL
- PRINCIPAL DISPLAY PANEL
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
DIMETHICONE
skin protectant creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68599-0218 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE 17.5 ug in 1 mg Inactive Ingredients Ingredient Name Strength OCTENYLSUCCINIC ACID (UNII: 12UZE4X73L) CARTHAMUS TINCTORIUS (SAFFLOWER) OLEOSOMES (UNII: 9S60Q72309) LEVOMENOL (UNII: 24WE03BX2T) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) EDETATE DISODIUM (UNII: 7FLD91C86K) KUKUI NUT OIL (UNII: TP11QR7B8R) STEARIC ACID (UNII: 4ELV7Z65AP) CETYL ALCOHOL (UNII: 936JST6JCN) GINGER (UNII: C5529G5JPQ) CALCIUM PANTOTHENATE (UNII: 568ET80C3D) PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) ARGININE (UNII: 94ZLA3W45F) ASPARTIC ACID (UNII: 30KYC7MIAI) PROLINE (UNII: 9DLQ4CIU6V) SERINE (UNII: 452VLY9402) ALANINE (UNII: OF5P57N2ZX) GLYCERIN (UNII: PDC6A3C0OX) PEG-100 STEARATE (UNII: YD01N1999R) CARTHAMUS TINCTORIUS FLOWER OIL (UNII: SDQ136WIM5) DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) HYALURONATE SODIUM (UNII: YSE9PPT4TH) WATER (UNII: 059QF0KO0R) NIACINAMIDE (UNII: 25X51I8RD4) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) VALINE (UNII: HG18B9YRS7) ISOLEUCINE (UNII: 04Y7590D77) PHENYLALANINE (UNII: 47E5O17Y3R) PHENOXYETHANOL (UNII: HIE492ZZ3T) CAPRYLYL GLYCOL (UNII: 00YIU5438U) MALTODEXTRIN (UNII: 7CVR7L4A2D) LYSINE (UNII: K3Z4F929H6) HISTIDINE (UNII: 4QD397987E) GLUTAMIC ACID (UNII: 3KX376GY7L) GLYCINE (UNII: TE7660XO1C) LEUCINE (UNII: GMW67QNF9C) ALOE VERA LEAF (UNII: ZY81Z83H0X) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR) TYROSINE (UNII: 42HK56048U) CHLORPHENESIN (UNII: I670DAL4SZ) TROLAMINE (UNII: 9O3K93S3TK) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68599-0218-4 118 mg in 1 TUBE; Type 0: Not a Combination Product 11/04/2019 2 NDC:68599-0218-8 946 mg in 1 BOTTLE; Type 0: Not a Combination Product 11/04/2019 3 NDC:68599-0218-1 1000 mg in 1 BAG; Type 0: Not a Combination Product 11/04/2019 01/01/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M016 11/04/2019 Labeler - McKesson (023904428) Establishment Name Address ID/FEI Business Operations Central Solutions 007118524 manufacture(68599-0218)