ANUBIS BARCELONA- dmae, zirhafirm cream

Anubis Barcelona by

Drug Labeling and Warnings

Anubis Barcelona by is a Otc medication manufactured, distributed, or labeled by ANUBIS COSMETICS SL, GDC OF FLORIDA IMPORTS, INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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, zirhafirm cream

Product 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)