Label: NIGHTLY FACE TREATMENT - DIMETHICONE- dimethicone cream
- NDC Code(s): 71593-101-11, 71593-101-51
- Packager: ARG LABORATORIES 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 January 9, 2023
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- USES
- WARNINGS
- KEEP OUT OF REACH OF CHILDREN
- DIRECTIONS
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INACTIVE INGREDIENTS
WATER (AQUA), ALOE BARBADENSIS LEAF JUICE, HYDROLYZED EGG SHELL MEMBRANE, NERIUM OLEANDER LEAF EXTRACT, NIACINAMIDE GLYCERIN, PROPANEDIOL,BUTYLENE GLYCOL, GLYCERYL STEARATE, Hydroxyethylacrylate/Sodium
Acryloyldimethyltaurate Copolymer, Hydrogenated Polydecene, Cocos Nucifera (Coconut) Oil, Caprylic/Capric Triglyceride, HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL, SQUALANE, Cetearyl Olivate, Sorbitan Olivate, C12-15 Alkyl Benzoate, Stearic Acid, LEUCONOSTOC/RADISH ROOT FERMENT, Butyrospermum Parkii (Shea) Butter, Theobroma Cacao (Cocoa) Seed Butter, Polysorbate 80, CAPRYLYL GLYCOL, SALVIA HISPANICA (CHIA) SEED OIL, ROSMARINUS OFFICINALIS (ROSEMARY) LEAF EXTRACT, Sodium Lactate, Tocopheryl Acetate, Xanthan Gum, Cymbopogon Schoenanthus Extract, Disodium EDTA, Acetyl Hexapeptide-30, Alteromonas Ferment Extract, Arginine, Caramel, POTASSIUM SORBATE, GLYCERYL CAPRYLATE, PHENYLPROPANOL, Limonene, Citral, Hydroxycitronellal, Linalool. - QUESTIONS?
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
NIGHTLY FACE TREATMENT - DIMETHICONE
dimethicone creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71593-101 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE 1.5 g in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) ALOE VERA LEAF (UNII: ZY81Z83H0X) EGG SHELL MEMBRANE (UNII: N7QBR4212V) NERIUM OLEANDER LEAF (UNII: 7KV510R6H6) NIACINAMIDE (UNII: 25X51I8RD4) GLYCERIN (UNII: PDC6A3C0OX) PROPANEDIOL (UNII: 5965N8W85T) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) (UNII: 86FQE96TZ4) HYDROGENATED POLYDECENE (550 MW) (UNII: U333RI6EB7) COCONUT OIL (UNII: Q9L0O73W7L) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) SUNFLOWER OIL (UNII: 3W1JG795YI) SQUALANE (UNII: GW89575KF9) CETEARYL OLIVATE (UNII: 58B69Q84JO) SORBITAN OLIVATE (UNII: MDL271E3GR) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) STEARIC ACID (UNII: 4ELV7Z65AP) LEUCONOSTOC/RADISH ROOT FERMENT FILTRATE (UNII: D2QHA03458) SHEA BUTTER (UNII: K49155WL9Y) COCOA BUTTER (UNII: 512OYT1CRR) POLYSORBATE 80 (UNII: 6OZP39ZG8H) CAPRYLYL GLYCOL (UNII: 00YIU5438U) SALVIA HISPANICA SEED (UNII: NU0OLX06F8) ROSEMARY (UNII: IJ67X351P9) SODIUM LACTATE (UNII: TU7HW0W0QT) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) XANTHAN GUM (UNII: TTV12P4NEE) CYMBOPOGON SCHOENANTHUS WHOLE (UNII: RJJ0F54DE8) EDETATE DISODIUM (UNII: 7FLD91C86K) ACETYL HEXAPEPTIDE-49 (UNII: 4055X1S509) ALTEROMONAS MACLEODII (UNII: BPX036043D) ARGININE (UNII: 94ZLA3W45F) CARAMEL (UNII: T9D99G2B1R) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A) PHENYLPROPANOL (UNII: 0F897O3O4M) LIMONENE, (+)- (UNII: GFD7C86Q1W) CITRAL (UNII: T7EU0O9VPP) HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR) LINALOOL, (+)- (UNII: F4VNO44C09) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:71593-101-51 1 in 1 BOX 12/06/2017 1 NDC:71593-101-11 30 mL in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part347 12/06/2017 Labeler - ARG LABORATORIES INC (117433599)