Label: ANUBISMED- sodium bicarbonate, aloe barbadensis leaf juice, imidazolidinyl urea liquid
- NDC Code(s): 83021-400-50
- 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 5, 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
ANUBISMED
sodium bicarbonate, aloe barbadensis leaf juice, imidazolidinyl urea liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:83021-400 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength IMIDUREA (UNII: M629807ATL) (IMIDUREA - UNII:M629807ATL) IMIDUREA 0.25 g in 50 mL ALOE VERA LEAF (UNII: ZY81Z83H0X) (ALOE VERA LEAF - UNII:ZY81Z83H0X) ALOE VERA LEAF 0.15 g in 50 mL WATER (UNII: 059QF0KO0R) (WATER - UNII:059QF0KO0R) WATER 45.8293 mL in 50 mL Inactive Ingredients Ingredient Name Strength SODIUM BICARBONATE (UNII: 8MDF5V39QO) 3.75 g in 50 mL SODIUM HYDROXIDE (UNII: 55X04QC32I) 0.02 g in 50 mL SODIUM BENZOATE (UNII: OJ245FE5EU) 0.00035 g in 50 mL POTASSIUM SORBATE (UNII: 1VPU26JZZ4) 0.00035 g in 50 mL Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:83021-400-50 50 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product 10/26/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final M016 10/26/2022 05/10/2027 Labeler - ANUBIS COSMETICS SL (468680293) Registrant - GDC OF FLORIDA IMPORTS, INC. (807003988) Establishment Name Address ID/FEI Business Operations ANUBIS COSMETICS SL 468680293 manufacture(83021-400)
