Label: PRESTIGE CAVIAR ESSENTIAL BARRIER EYE CREAM- dimethicone cream
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Contains inactivated NDC Code(s)
NDC Code(s): 70519-001-01, 70519-001-02 - Packager: FW1 R&D_Branch
- 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 June 27, 2017
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- DOSAGE & ADMINISTRATION
- WARNINGS
- KEEP OUT OF REACH OF CHILDREN
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INACTIVE INGREDIENT
Caviar Extract, Petrolatum, Glycerin, Butyrospermum Parkii (Shea) Butter, Ceresin, Phenyl Trimethicone, Water, Polyglyceryl-2 Dipolyhydroxystearate, Cetyl PEG/PPG-10/1 Dimethicone, Butylene Glycol, Niacinamide, Pentylene Glycol, Beeswax, Sodium Chloride, 1,2-Hexanediol, Silica, PEG-7 Dimethicone, Hydroxystearic Acid, Phenoxyethanol, Fragrance(Parfum), Disodium EDTA, Adenosine, Iron Oxides (CI 77499), Aqua, Hydrolyzed Rice Protein, Sodium Benzoate, Superoxide Dismutase, Glycine Soja (Soybean) Protein, Polydecene, Saccharide Isomerate, Sodium Dextran Sulfate, Potassium Sorbate, Caprylic/Capric Triglyceride, Sorbitan Laurate, Squalane, Hydrogenated Lecithin, Viscum Album (Mistletoe) Fruit Extract, Ceramide 3, Hydroxyethylcellulose, Acetyl Dipeptide-1 Cetyl Ester, Sodium Citrate, Citric Acid, Prunus Persica (Peach) Flower Extract
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
PRESTIGE CAVIAR ESSENTIAL BARRIER EYE CREAM
dimethicone creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70519-001 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE 1.5 mg in 30 mL Inactive Ingredients Ingredient Name Strength CAVIAR, UNSPECIFIED (UNII: 020K6HLU0O) PETROLATUM (UNII: 4T6H12BN9U) GLYCERIN (UNII: PDC6A3C0OX) SHEA BUTTER (UNII: K49155WL9Y) CERESIN (UNII: Q1LS2UJO3A) PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R) WATER (UNII: 059QF0KO0R) POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12) CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) NIACINAMIDE (UNII: 25X51I8RD4) PENTYLENE GLYCOL (UNII: 50C1307PZG) YELLOW WAX (UNII: 2ZA36H0S2V) SODIUM CHLORIDE (UNII: 451W47IQ8X) 1,2-HEXANEDIOL (UNII: TR046Y3K1G) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) 12-HYDROXYSTEARIC ACID (UNII: 933ANU3H2S) PHENOXYETHANOL (UNII: HIE492ZZ3T) EDETATE DISODIUM (UNII: 7FLD91C86K) ADENOSINE (UNII: K72T3FS567) FERROSOFERRIC OXIDE (UNII: XM0M87F357) SODIUM BENZOATE (UNII: OJ245FE5EU) LEDISMASE (UNII: 0786H5RV0T) SOY PROTEIN (UNII: R44IWB3RN5) HYDROGENATED DIDECENE (UNII: 048B98MT5O) SACCHARIDE ISOMERATE (UNII: W8K377W98I) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) SORBITAN MONOLAURATE (UNII: 6W9PS8B71J) SQUALANE (UNII: GW89575KF9) HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N) VISCUM ALBUM FRUIT (UNII: P83EQ521R3) CERAMIDE NP (UNII: 4370DF050B) HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%) (UNII: R33S7TK2EP) ACETYL TYROSYLARGININE CETYL ESTER (UNII: 3M7W78X5IR) SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) PRUNUS PERSICA FLOWER (UNII: 19GWB0JENH) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70519-001-02 1 in 1 PACKAGE 06/27/2017 1 NDC:70519-001-01 30 mL in 1 CONTAINER; 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 06/27/2017 Labeler - FW1 R&D_Branch (689605458) Registrant - FW1 R&D_Branch (689605458) Establishment Name Address ID/FEI Business Operations Cosmax, Inc 689049693 manufacture(70519-001)
