Label: HYDRAFACE- glycerin, dimethicone cream
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Contains inactivated NDC Code(s)
NDC Code(s): 70663-009-01, 70663-009-02 - Packager: MESO SYSTEM S A
- 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 December 17, 2016
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- Official Label (Printer Friendly)
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INACTIVE INGREDIENT
Water,Stearyl Alcohol, Steareth-2, Isopropyl Myristate, Sodium Lactate, Serine, Imidazolidinyl Urea. Phenoxyethanol.. Tea-Lactate
Tocopheryl Acetate.Lactic Acid. Ethylhexyl Methoxycinnamate.. Mimosa Tenuiflora Extract, Decyl Oleate, Steareth-21, Sorbitol, Glyceryl Linoleate, Glyceryl Linolenate,Glyceryl Arachidonate,BHT, Ethylhexylglycerin, Retinyl Palmitate, Butylphenyl Methylpropional, D-limonene, Linalool, Parfum
- Warnings
- WARNINGS
- USES
- USES
- KEEP OUT OF REACH OF CHILDREN
- DIRECTIONS
- QUESTIONS OR COMMENTS?
- ACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
HYDRAFACE
glycerin, dimethicone creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70663-009 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN 2 mg in 1 mL DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE 0.1 mg in 1 mL Inactive Ingredients Ingredient Name Strength GLYCERYL LINOLENATE (UNII: SGB6X4G86K) 0.1 mg in 1 mL PHENOXYETHANOL (UNII: HIE492ZZ3T) 0.9 mg in 1 mL DECYL OLEATE (UNII: ZGR06DO97T) 0.1 mg in 1 mL STEARETH-21 (UNII: 53J3F32P58) 0.1 mg in 1 mL SORBITOL (UNII: 506T60A25R) 0.1 mg in 1 mL STEARETH-2 (UNII: V56DFE46J5) 4 mg in 1 mL STEARYL ALCOHOL (UNII: 2KR89I4H1Y) 4 mg in 1 mL WATER (UNII: 059QF0KO0R) 76.65 mg in 1 mL ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) 4 mg in 1 mL SODIUM LACTATE (UNII: TU7HW0W0QT) 2 mg in 1 mL SERINE (UNII: 452VLY9402) 2 mg in 1 mL IMIDUREA (UNII: M629807ATL) 2 mg in 1 mL TRIETHANOLAMINE LACTATE (UNII: 064C51N81O) 0.5 mg in 1 mL ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) 0.3 mg in 1 mL LACTIC ACID (UNII: 33X04XA5AT) 0.1 mg in 1 mL ETHYLHEXYL METHOXYCRYLENE (UNII: S3KFG6Q5X8) 0.1 mg in 1 mL MIMOSA TENUIFLORA LEAF (UNII: 46VJM10Q45) 0.1 mg in 1 mL BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) 0.1 mg in 1 mL VITAMIN A PALMITATE (UNII: 1D1K0N0VVC) 0.1 mg in 1 mL BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69) 0.1 mg in 1 mL LIMONENE, (+)- (UNII: GFD7C86Q1W) 0.1 mg in 1 mL LINALOOL, (+)- (UNII: F4VNO44C09) 0.1 mg in 1 mL PEG-30 GLYCERYL LINOLEATE (UNII: UPJ8VI2ZOC) 0.1 mg in 1 mL GLYCERYL ARACHIDONATE (UNII: I4WS2B978B) 0.1 mg in 1 mL ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) 0.1 mg in 1 mL PERFLUNAFENE (UNII: 54A06VV62N) 0.05 mg in 1 mL Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70663-009-02 50 in 1 CARTON 12/17/2016 1 NDC:70663-009-01 50 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 12/17/2016 Labeler - MESO SYSTEM S A (768263100) Registrant - Meso Systems S A (768263100) Establishment Name Address ID/FEI Business Operations Meso Systems S A 768263100 manufacture(70663-009)
