Label: ANUBIS BARCELONA NEW EVEN- lactic acid, citric acid, glycolic acid lotion
- NDC Code(s): 83021-033-01
- 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
- PURPOSE
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ANUBIS BARCELONA NEW EVEN
lactic acid, citric acid, glycolic acid lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:83021-033 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength FD&C BLUE NO. 1 (UNII: H3R47K3TBD) (FD&C BLUE NO. 1 - UNII:H3R47K3TBD) FD&C BLUE NO. 1 0.0005 g in 250 mL LACTIC ACID (UNII: 33X04XA5AT) (LACTIC ACID - UNII:33X04XA5AT) LACTIC ACID 2.348125 g in 250 mL POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F) (POLYOXYL 40 HYDROGENATED CASTOR OIL - UNII:7YC686GQ8F) POLYOXYL 40 HYDROGENATED CASTOR OIL 1.25 g in 250 mL TROLAMINE (UNII: 9O3K93S3TK) (TROLAMINE - UNII:9O3K93S3TK) TROLAMINE 0.5 g in 250 mL .ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I) (.ALPHA.-HEXYLCINNAMALDEHYDE - UNII:7X6O37OK2I) .ALPHA.-HEXYLCINNAMALDEHYDE 0.0150375 g in 250 mL LINALOOL, (+/-)- (UNII: D81QY6I88E) (LINALOOL, (+/-)- - UNII:D81QY6I88E) LINALOOL, (+/-)- 0.0041025 g in 250 mL BENZOIC ACID (UNII: 8SKN0B0MIM) (BENZOIC ACID - UNII:8SKN0B0MIM) BENZOIC ACID 0.625 g in 250 mL PHENOXYETHANOL (UNII: HIE492ZZ3T) (PHENOXYETHANOL - UNII:HIE492ZZ3T) PHENOXYETHANOL 2.5 g in 250 mL GLYCOLIC ACID (UNII: 0WT12SX38S) (GLYCOLIC ACID - UNII:0WT12SX38S) GLYCOLIC ACID 1.220625 g in 250 mL WATER (UNII: 059QF0KO0R) (WATER - UNII:059QF0KO0R) WATER 228.15635 mL in 250 mL ALLANTOIN (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z) ALLANTOIN 0.75 g in 250 mL DEHYDROACETIC ACID (UNII: 2KAG279R6R) (DEHYDROACETIC ACID - UNII:2KAG279R6R) DEHYDROACETIC ACID 0.25 g in 250 mL DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B) (DIETHYLENE GLYCOL MONOETHYL ETHER - UNII:A1A1I8X02B) DIETHYLENE GLYCOL MONOETHYL ETHER 0.75 g in 250 mL FRAGRANCE 13576 (UNII: 5EM498GW35) (FRAGRANCE 13576 - UNII:5EM498GW35) FRAGRANCE 13576 0.075 g in 250 mL LIMONENE, (+)- (UNII: GFD7C86Q1W) (LIMONENE, (+)- - UNII:GFD7C86Q1W) LIMONENE, (+)- 0.022755 g in 250 mL PROPYLENE GLYCOL (UNII: 6DC9Q167V3) (PROPYLENE GLYCOL - UNII:6DC9Q167V3) PROPYLENE GLYCOL 10.5 g in 250 mL Inactive Ingredients Ingredient Name Strength CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) 0.47 g in 250 mL SODIUM HYDROXIDE (UNII: 55X04QC32I) 0.9375 g in 250 mL Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:83021-033-01 250 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product 10/13/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final M016 10/13/2022 01/13/2027 Labeler - ANUBIS COSMETICS SL (468680293) Registrant - GDC OF FLORIDA IMPORTS, INC. (807003988) Establishment Name Address ID/FEI Business Operations ANUBIS COSMETICS SL 468680293 manufacture(83021-033)
