Label: ANUBIS BARCELONA TOTAL HYDRATING- betaine, glycerin, polysorbate 20 lotion
- NDC Code(s): 83021-692-01
- 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 TOTAL HYDRATING
betaine, glycerin, polysorbate 20 lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:83021-692 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BETAINE (UNII: 3SCV180C9W) (BETAINE - UNII:3SCV180C9W) BETAINE 5 g in 250 mL FRAGRANCE 13576 (UNII: 5EM498GW35) (FRAGRANCE 13576 - UNII:5EM498GW35) FRAGRANCE 13576 0.125 g in 250 mL FD&C BLUE NO. 1 (UNII: H3R47K3TBD) (FD&C BLUE NO. 1 - UNII:H3R47K3TBD) FD&C BLUE NO. 1 0.00025 g in 250 mL BENZOIC ACID (UNII: 8SKN0B0MIM) (BENZOIC ACID - UNII:8SKN0B0MIM) BENZOIC ACID 1.75 g in 250 mL GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN 5 g in 250 mL PHENOXYETHANOL (UNII: HIE492ZZ3T) (PHENOXYETHANOL - UNII:HIE492ZZ3T) PHENOXYETHANOL 2.25 g in 250 mL ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) (ETHYLHEXYLGLYCERIN - UNII:147D247K3P) ETHYLHEXYLGLYCERIN 0.125 g in 250 mL POLYSORBATE 20 (UNII: 7T1F30V5YH) (POLYSORBATE 20 - UNII:7T1F30V5YH) POLYSORBATE 20 2.75 g in 250 mL WATER (UNII: 059QF0KO0R) (WATER - UNII:059QF0KO0R) WATER 232.139 mL in 250 mL IMIDUREA (UNII: M629807ATL) (IMIDUREA - UNII:M629807ATL) IMIDUREA 0.75 g in 250 mL Inactive Ingredients Ingredient Name Strength DEHYDROACETIC ACID (UNII: 2KAG279R6R) 0.1 g in 250 mL Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:83021-692-01 250 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 09/12/2027 Labeler - ANUBIS COSMETICS SL (468680293) Registrant - GDC OF FLORIDA IMPORTS, INC. (807003988) Establishment Name Address ID/FEI Business Operations ANUBIS COSMETICS SL 468680293 manufacture(83021-692)
