Label: ANUBISMED- aloe barbadensis leaf extract, propylene glycol, cetearyl ethylhexanoate cream
- NDC Code(s): 83021-774-15
- 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
- INDICATIONS & USAGE
- DO NOT USE
- KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- WARNINGS
- INACTIVE INGREDIENT
- PURPOSE
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INGREDIENTS AND APPEARANCE
ANUBISMED
aloe barbadensis leaf extract, propylene glycol, cetearyl ethylhexanoate creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:83021-774 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN 0.15 g in 15 mL WATER (UNII: 059QF0KO0R) (WATER - UNII:059QF0KO0R) WATER 11.358 mL in 15 mL IMIDUREA (UNII: M629807ATL) (IMIDUREA - UNII:M629807ATL) IMIDUREA 0.045 g in 15 mL FRAGRANCE 13576 (UNII: 5EM498GW35) (FRAGRANCE 13576 - UNII:5EM498GW35) FRAGRANCE 13576 0.0375 g in 15 mL TROPOLONE (UNII: 7L6DL16P1T) (TROPOLONE - UNII:7L6DL16P1T) TROPOLONE 0.0012 g in 15 mL SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4) SILICON DIOXIDE 0.0024 g in 15 mL CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC) (CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE - UNII:0A5MM307FC) CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE 0.12 g in 15 mL TROLAMINE (UNII: 9O3K93S3TK) (TROLAMINE - UNII:9O3K93S3TK) TROLAMINE 0.12 g in 15 mL BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) (BUTYLATED HYDROXYTOLUENE - UNII:1P9D0Z171K) BUTYLATED HYDROXYTOLUENE 0.015 g in 15 mL HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9) (HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER - UNII:WB5K9Y35Y9) HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER 0.1176 g in 15 mL ARGAN OIL (UNII: 4V59G5UW9X) (ARGAN OIL - UNII:4V59G5UW9X) ARGAN OIL 0.075 g in 15 mL DECYL OLEATE (UNII: ZGR06DO97T) (DECYL OLEATE - UNII:ZGR06DO97T) DECYL OLEATE 0.2999994 g in 15 mL ALLANTOIN (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z) ALLANTOIN 0.015 g in 15 mL C12-20 ACID PEG-8 ESTER (UNII: 9M7A3K4339) (C12-20 ACID PEG-8 ESTER - UNII:9M7A3K4339) C12-20 ACID PEG-8 ESTER 0.15 g in 15 mL ALOE VERA LEAF (UNII: ZY81Z83H0X) (ALOE VERA LEAF - UNII:ZY81Z83H0X) ALOE VERA LEAF 0.6 g in 15 mL PROPYLENE GLYCOL (UNII: 6DC9Q167V3) (PROPYLENE GLYCOL - UNII:6DC9Q167V3) PROPYLENE GLYCOL 0.6 g in 15 mL BUTYROSPERMUM PARKII (SHEA) BUTTER UNSAPONIFIABLES (UNII: 0C9AC7D6XU) (BUTYROSPERMUM PARKII (SHEA) BUTTER UNSAPONIFIABLES - UNII:0C9AC7D6XU) BUTYROSPERMUM PARKII (SHEA) BUTTER UNSAPONIFIABLES 0.15 g in 15 mL CAPRYLYL GLYCOL (UNII: 00YIU5438U) (CAPRYLYL GLYCOL - UNII:00YIU5438U) CAPRYLYL GLYCOL 0.0588 g in 15 mL MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) (MEDIUM-CHAIN TRIGLYCERIDES - UNII:C9H2L21V7U) MEDIUM-CHAIN TRIGLYCERIDES 0.375 g in 15 mL TOCOPHEROL (UNII: R0ZB2556P8) (TOCOPHEROL - UNII:R0ZB2556P8) TOCOPHEROL 0.0000006 g in 15 mL 1,2-HEXANEDIOL (UNII: TR046Y3K1G) (1,2-HEXANEDIOL - UNII:TR046Y3K1G) 1,2-HEXANEDIOL 0.06 g in 15 mL GRAPE SEED OIL (UNII: 930MLC8XGG) (GRAPE SEED OIL - UNII:930MLC8XGG) GRAPE SEED OIL 0.15 g in 15 mL Inactive Ingredients Ingredient Name Strength CETYL PHOSPHATE (UNII: VT07D6X67O) 0.0045 g in 15 mL CETEARYL ETHYLHEXANOATE (UNII: 9M64UO4C25) 0.375 g in 15 mL .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) 0.03 g in 15 mL HYALURONATE SODIUM (UNII: YSE9PPT4TH) 0.075 g in 15 mL EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM) 0.015 g in 15 mL Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:83021-774-15 15 mL in 1 TUBE; Type 0: Not a Combination Product 10/14/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final M016 10/14/2022 02/03/2026 Labeler - ANUBIS COSMETICS SL (468680293) Registrant - GDC OF FLORIDA IMPORTS, INC. (807003988) Establishment Name Address ID/FEI Business Operations ANUBIS COSMETICS SL 468680293 manufacture(83021-774)