ANUBIS BARCELONA- glycerin, sorbitol, aloe barbadensis leaf juice concentrate 
ANUBIS COSMETICS SL

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.

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7 Days

7 Days Indications

Do not use

Keep out of children

Dosage n Administration

Warning

Inactive

7 Days Purpose

Package Label

ANUBIS BARCELONA 
glycerin, sorbitol, aloe barbadensis leaf juice concentrate
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83021-877
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SORBITOL (UNII: 506T60A25R) (SORBITOL - UNII:506T60A25R) SORBITOL0.0525 g  in 1.5 mL
SACCHAROMYCES LYSATE (UNII: R85W246Z1C) (SACCHAROMYCES LYSATE - UNII:R85W246Z1C) SACCHAROMYCES LYSATE0.00075 g  in 1.5 mL
WATER (UNII: 059QF0KO0R) (WATER - UNII:059QF0KO0R) WATER1.219341 mL  in 1.5 mL
1,2-HEXANEDIOL (UNII: TR046Y3K1G) (1,2-HEXANEDIOL - UNII:TR046Y3K1G) 1,2-HEXANEDIOL0.0165 g  in 1.5 mL
GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN0.16875 g  in 1.5 mL
LEUCONOSTOC/RADISH ROOT FERMENT FILTRATE (UNII: D2QHA03458) (LEUCONOSTOC/RADISH ROOT FERMENT FILTRATE - UNII:D2QHA03458) LEUCONOSTOC/RADISH ROOT FERMENT FILTRATE0.000015 g  in 1.5 mL
HYALURONATE SODIUM (UNII: YSE9PPT4TH) (HYALURONIC ACID - UNII:S270N0TRQY) HYALURONATE SODIUM0.0075 g  in 1.5 mL
FD&C BLUE NO. 1 (UNII: H3R47K3TBD) (FD&C BLUE NO. 1 - UNII:H3R47K3TBD) FD&C BLUE NO. 10.000009 g  in 1.5 mL
PHENOXYETHANOL (UNII: HIE492ZZ3T) (PHENOXYETHANOL - UNII:HIE492ZZ3T) PHENOXYETHANOL0.0141 g  in 1.5 mL
ALOE VERA LEAF (UNII: ZY81Z83H0X) (ALOE VERA LEAF - UNII:ZY81Z83H0X) ALOE VERA LEAF0.008955 g  in 1.5 mL
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) (ETHYLHEXYLGLYCERIN - UNII:147D247K3P) ETHYLHEXYLGLYCERIN0.0015 g  in 1.5 mL
Inactive Ingredients
Ingredient NameStrength
CAESALPINIA SPINOSA RESIN (UNII: WL3883U2PO) 0.00675 g  in 1.5 mL
SODIUM BENZOATE (UNII: OJ245FE5EU) 0.00003 g  in 1.5 mL
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM) 0.003 g  in 1.5 mL
POTASSIUM SORBATE (UNII: 1VPU26JZZ4) 0.0003 g  in 1.5 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:83021-877-071.5 mL in 1 VIAL, SINGLE-USE; Type 0: Not a Combination Product02/21/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalM01610/19/202201/14/2027
Labeler - ANUBIS COSMETICS SL (468680293)
Registrant - GDC OF FLORIDA IMPORTS, INC. (807003988)
Establishment
NameAddressID/FEIBusiness Operations
ANUBIS COSMETICS SL468680293manufacture(83021-877)

Revised: 9/2023
Document Id: 04522475-b44b-eb2f-e063-6294a90afc2b
Set id: eb651769-4d98-2b3b-e053-2a95a90a36b0
Version: 2
Effective Time: 20230901
 
ANUBIS COSMETICS SL