Label: ANUBIS BARCELONA- dmae concentrate
- NDC Code(s): 83021-546-30
- 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 1, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- INDICATIONS & USAGE
- DO NOT USE
- KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- WARNINGS
- INACTIVE INGREDIENT
- PURPOSE
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
ANUBIS BARCELONA
dmae concentrateProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:83021-546 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN 0.555 g in 30 mL PHENOXYETHANOL (UNII: HIE492ZZ3T) (PHENOXYETHANOL - UNII:HIE492ZZ3T) PHENOXYETHANOL 0.243 g in 30 mL XANTHAN GUM (UNII: TTV12P4NEE) (XANTHAN GUM - UNII:TTV12P4NEE) XANTHAN GUM 0.09 g in 30 mL FRAGRANCE 13576 (UNII: 5EM498GW35) (FRAGRANCE 13576 - UNII:5EM498GW35) FRAGRANCE 13576 0.027 g in 30 mL SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4) (SORBITAN ISOSTEARATE - UNII:01S2G2C1E4) SORBITAN ISOSTEARATE 0.024 g in 30 mL HYDROLYZED BOVINE ELASTIN (BASE; 1000 MW) (UNII: ZR28QKN0WT) (HYDROLYZED BOVINE ELASTIN (BASE; 1000 MW) - UNII:ZR28QKN0WT) HYDROLYZED BOVINE ELASTIN (BASE; 1000 MW) 0.0012 g in 30 mL LIMONENE, (+)- (UNII: GFD7C86Q1W) (LIMONENE, (+)- - UNII:GFD7C86Q1W) LIMONENE, (+)- 0.0009 g in 30 mL TOCOPHEROL (UNII: R0ZB2556P8) (TOCOPHEROL - UNII:R0ZB2556P8) TOCOPHEROL 0.0003 g in 30 mL HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR) (HYDROXYCITRONELLAL - UNII:8SQ0VA4YUR) HYDROXYCITRONELLAL 0.0006 g in 30 mL POLYSORBATE 60 (UNII: CAL22UVI4M) (POLYSORBATE 60 - UNII:CAL22UVI4M) POLYSORBATE 60 0.024 g in 30 mL LECITHIN, SOYBEAN (UNII: 1DI56QDM62) (LECITHIN, SOYBEAN - UNII:1DI56QDM62) LECITHIN, SOYBEAN 0.45 g in 30 mL HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) (UNII: 86FQE96TZ4) (HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) - UNII:86FQE96TZ4) HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) 0.405 g in 30 mL DEHYDROACETIC ACID (UNII: 2KAG279R6R) (DEHYDROACETIC ACID - UNII:2KAG279R6R) DEHYDROACETIC ACID 0.021 g in 30 mL PROPANEDIOL (UNII: 5965N8W85T) (PROPANEDIOL - UNII:5965N8W85T) PROPANEDIOL 1.08 g in 30 mL DICAPRYLYL ETHER (UNII: 77JZM5516Z) (DICAPRYLYL ETHER - UNII:77JZM5516Z) DICAPRYLYL ETHER 0.9 g in 30 mL BENZOIC ACID (UNII: 8SKN0B0MIM) (BENZOIC ACID - UNII:8SKN0B0MIM) BENZOIC ACID 0.036 g in 30 mL ASCORBYL GLUCOSIDE (UNII: 2V52R0NHXW) (ASCORBYL GLUCOSIDE - UNII:2V52R0NHXW) ASCORBYL GLUCOSIDE 0.15 g in 30 mL WATER (UNII: 059QF0KO0R) (WATER - UNII:059QF0KO0R) WATER 25.5564 mL in 30 mL Inactive Ingredients Ingredient Name Strength DEANOL BITARTRATE (UNII: D240J05W14) 0.15 g in 30 mL HYALURONATE SODIUM (UNII: YSE9PPT4TH) 0.15 g in 30 mL PHYTATE SODIUM (UNII: 88496G1ERL) 0.024 g in 30 mL CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) 0.006 g in 30 mL SODIUM BENZOATE (UNII: OJ245FE5EU) 0.0006 g in 30 mL SODIUM HYDROXIDE (UNII: 55X04QC32I) 0.015 g in 30 mL TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K) 0.09 g in 30 mL Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:83021-546-30 30 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product 01/13/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final M016 01/13/2023 08/05/2027 Labeler - ANUBIS COSMETICS SL (468680293) Registrant - GDC OF FLORIDA IMPORTS, INC. (807003988) Establishment Name Address ID/FEI Business Operations ANUBIS COSMETICS SL 468680293 manufacture(83021-546)
