Label: ANUBIS BARCELONA- dmae, zirhafirm cream
- NDC Code(s): 83021-553-60
- 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
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- ACTIVE INGREDIENT
- INDICATIONS & USAGE
- DO NOT USE
- KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- WARNINGS
- INACTIVE INGREDIENT
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INGREDIENTS AND APPEARANCE
ANUBIS BARCELONA
dmae, zirhafirm creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:83021-553 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALOE VERA LEAF (UNII: ZY81Z83H0X) (ALOE VERA LEAF - UNII:ZY81Z83H0X) ALOE VERA LEAF 5.988 g in 60 mL LINALOOL, (+/-)- (UNII: D81QY6I88E) (LINALOOL, (+/-)- - UNII:D81QY6I88E) LINALOOL, (+/-)- 0.0006 g in 60 mL EUGENOL (UNII: 3T8H1794QW) (EUGENOL - UNII:3T8H1794QW) EUGENOL 0.0006 g in 60 mL PROPANEDIOL (UNII: 5965N8W85T) (PROPANEDIOL - UNII:5965N8W85T) PROPANEDIOL 2.496 g in 60 mL BENZYL ALCOHOL (UNII: LKG8494WBH) (BENZYL ALCOHOL - UNII:LKG8494WBH) BENZYL ALCOHOL 0.456 g in 60 mL CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) (CETOSTEARYL ALCOHOL - UNII:2DMT128M1S) CETOSTEARYL ALCOHOL 1.2 g in 60 mL DICAPRYLYL ETHER (UNII: 77JZM5516Z) (DICAPRYLYL ETHER - UNII:77JZM5516Z) DICAPRYLYL ETHER 1.5 g in 60 mL SORBIC ACID (UNII: X045WJ989B) (SORBIC ACID - UNII:X045WJ989B) SORBIC ACID 0.024 g in 60 mL XANTHAN GUM (UNII: TTV12P4NEE) (XANTHAN GUM - UNII:TTV12P4NEE) XANTHAN GUM 0.18 g in 60 mL .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K) (.BETA.-CITRONELLOL, (R)- - UNII:P01OUT964K) .BETA.-CITRONELLOL, (R)- 0.0006 g in 60 mL GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) (GLYCERYL MONOSTEARATE - UNII:230OU9XXE4) GLYCERYL MONOSTEARATE 2.4 g in 60 mL FRAGRANCE 13576 (UNII: 5EM498GW35) (FRAGRANCE 13576 - UNII:5EM498GW35) FRAGRANCE 13576 0.114 g in 60 mL SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID 0.09 g in 60 mL JUJUBE SEED (UNII: I51YGQ1Q2L) (JUJUBE SEED - UNII:I51YGQ1Q2L) JUJUBE SEED 0.048 g in 60 mL LECITHIN, SOYBEAN (UNII: 1DI56QDM62) (LECITHIN, SOYBEAN - UNII:1DI56QDM62) LECITHIN, SOYBEAN 0.036 g in 60 mL BAICALIN (UNII: 347Q89U4M5) (BAICALIN - UNII:347Q89U4M5) BAICALIN 0.012 g in 60 mL LEUZEA CARTHAMOIDES ROOT (UNII: P8CUH2KYHL) (LEUZEA CARTHAMOIDES ROOT - UNII:P8CUH2KYHL) LEUZEA CARTHAMOIDES ROOT 0.012 g in 60 mL WATER (UNII: 059QF0KO0R) (WATER - UNII:059QF0KO0R) WATER 33.2616 mL in 60 mL LIMONENE, (+)- (UNII: GFD7C86Q1W) (LIMONENE, (+)- - UNII:GFD7C86Q1W) LIMONENE, (+)- 0.006 g in 60 mL HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR) (HYDROXYCITRONELLAL - UNII:8SQ0VA4YUR) HYDROXYCITRONELLAL 0.0024 g in 60 mL TOCOPHEROL (UNII: R0ZB2556P8) (TOCOPHEROL - UNII:R0ZB2556P8) TOCOPHEROL 0.0018 g in 60 mL GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN 3.036 g in 60 mL DECYL OLEATE (UNII: ZGR06DO97T) (DECYL OLEATE - UNII:ZGR06DO97T) DECYL OLEATE 3.9 g in 60 mL SHEA BUTTER (UNII: K49155WL9Y) (SHEA BUTTER - UNII:K49155WL9Y) SHEA BUTTER 2.1 g in 60 mL Inactive Ingredients Ingredient Name Strength SODIUM HYDROXIDE (UNII: 55X04QC32I) 0.042 g in 60 mL POTASSIUM SORBATE (UNII: 1VPU26JZZ4) 0.012 g in 60 mL CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) 0.0018 g in 60 mL PHYTATE SODIUM (UNII: 88496G1ERL) 0.054 g in 60 mL HYDROGENATED PALM GLYCERIDES CITRATE (UNII: 23AS6RA25L) 0.0006 g in 60 mL DEANOL BITARTRATE (UNII: D240J05W14) 0.012 g in 60 mL SODIUM BENZOATE (UNII: OJ245FE5EU) 0.006 g in 60 mL HYALURONATE SODIUM (UNII: YSE9PPT4TH) 0.006 g in 60 mL GLYCERYL STEARATE CITRATE (UNII: WH8T92A065) 3 g in 60 mL Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:83021-553-60 60 mL in 1 JAR; 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 03/06/2028 Labeler - ANUBIS COSMETICS SL (468680293) Registrant - GDC OF FLORIDA IMPORTS, INC. (807003988) Establishment Name Address ID/FEI Business Operations ANUBIS COSMETICS SL 468680293 manufacture(83021-553)
