Label: ANUBISMED- ha hyaluronic cream
- NDC Code(s): 83021-750-50
- Packager: ANUBIS COSMETICS SL
- 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 September 5, 2023
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- ACTIVE INGREDIENT
- INACTIVE INGREDIENT
- INDICATIONS & USAGE
- DO NOT USE
- KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- WARNINGS
- PURPOSE
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ANUBISMED
ha hyaluronic creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:83021-750 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALLANTOIN (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z) ALLANTOIN 0.05 g in 50 mL ALOE VERA LEAF (UNII: ZY81Z83H0X) (ALOE VERA LEAF - UNII:ZY81Z83H0X) ALOE VERA LEAF 2.5 g in 50 mL FRAGRANCE 13576 (UNII: 5EM498GW35) (FRAGRANCE 13576 - UNII:5EM498GW35) FRAGRANCE 13576 0.225 g in 50 mL GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) (GLYCERYL MONOSTEARATE - UNII:230OU9XXE4) GLYCERYL MONOSTEARATE 0.875 g in 50 mL TROLAMINE (UNII: 9O3K93S3TK) (TROLAMINE - UNII:9O3K93S3TK) TROLAMINE 0.3 g in 50 mL BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) (BUTYLATED HYDROXYTOLUENE - UNII:1P9D0Z171K) BUTYLATED HYDROXYTOLUENE 0.0535 g in 50 mL PROPYLENE GLYCOL (UNII: 6DC9Q167V3) (PROPYLENE GLYCOL - UNII:6DC9Q167V3) PROPYLENE GLYCOL 1.996 g in 50 mL CETYL ALCOHOL (UNII: 936JST6JCN) (CETYL ALCOHOL - UNII:936JST6JCN) CETYL ALCOHOL 0.0038 g in 50 mL TROPOLONE (UNII: 7L6DL16P1T) (TROPOLONE - UNII:7L6DL16P1T) TROPOLONE 0.004 g in 50 mL TOCOPHEROL (UNII: R0ZB2556P8) (TOCOPHEROL - UNII:R0ZB2556P8) TOCOPHEROL 0.0004 g in 50 mL DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE 0.25 g in 50 mL 1,2-HEXANEDIOL (UNII: TR046Y3K1G) (1,2-HEXANEDIOL - UNII:TR046Y3K1G) 1,2-HEXANEDIOL 0.198 g in 50 mL IMIDUREA (UNII: M629807ATL) (IMIDUREA - UNII:M629807ATL) IMIDUREA 0.15 g in 50 mL CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC) (CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE - UNII:0A5MM307FC) CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE 0.25 g in 50 mL CETEARYL ETHYLHEXANOATE (UNII: 9M64UO4C25) (CETEARYL ETHYLHEXANOATE - UNII:9M64UO4C25) CETEARYL ETHYLHEXANOATE 1.75 g in 50 mL MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) (MEDIUM-CHAIN TRIGLYCERIDES - UNII:C9H2L21V7U) MEDIUM-CHAIN TRIGLYCERIDES 1.5 g in 50 mL CAPRYLYL GLYCOL (UNII: 00YIU5438U) (CAPRYLYL GLYCOL - UNII:00YIU5438U) CAPRYLYL GLYCOL 0.198 g in 50 mL OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 3.4965 g in 50 mL GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN 0.4975 g in 50 mL GLYCERYL STEARATE SE (UNII: FCZ5MH785I) (GLYCERYL STEARATE SE - UNII:FCZ5MH785I) GLYCERYL STEARATE SE 1.5 g in 50 mL WATER (UNII: 059QF0KO0R) (WATER - UNII:059QF0KO0R) WATER 27.4065 mL in 50 mL C12-20 ACID PEG-8 ESTER (UNII: 9M7A3K4339) (C12-20 ACID PEG-8 ESTER - UNII:9M7A3K4339) C12-20 ACID PEG-8 ESTER 2.25 g in 50 mL OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 2 g in 50 mL DECYL OLEATE (UNII: ZGR06DO97T) (DECYL OLEATE - UNII:ZGR06DO97T) DECYL OLEATE 1.9996 g in 50 mL Inactive Ingredients Ingredient Name Strength CETYL PHOSPHATE (UNII: VT07D6X67O) 0.1463 g in 50 mL SODIUM CHONDROITIN SULFATE (PORCINE; 5500 MW) (UNII: H5BJH23Z9A) 0.05 g in 50 mL HYALURONATE SODIUM (UNII: YSE9PPT4TH) 0.25 g in 50 mL .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) 0.1 g in 50 mL Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:83021-750-50 50 mL in 1 JAR; Type 0: Not a Combination Product 10/17/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final M016 10/17/2022 01/16/2028 Labeler - ANUBIS COSMETICS SL (468680293) Registrant - GDC OF FLORIDA IMPORTS, INC. (807003988) Establishment Name Address ID/FEI Business Operations ANUBIS COSMETICS SL 468680293 manufacture(83021-750)