Label: NIACINAMIDE B3 SERUM solution
- NDC Code(s): 84785-0006-1, 84785-0006-2
- Packager: Gazebo Wellness SKIN LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated December 16, 2024
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INGREDIENTS AND APPEARANCE
NIACINAMIDE B3 SERUM
niacinamide b3 serum solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:84785-0006 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 0.3 mg in 30 mL ROSEMARY (UNII: IJ67X351P9) (ROSEMARY - UNII:IJ67X351P9) ROSEMARY 0.3 mg in 30 mL HYALURONIC ACID (UNII: S270N0TRQY) (HYALURONIC ACID - UNII:S270N0TRQY) HYALURONIC ACID 0.3 mg in 30 mL NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4) NIACINAMIDE 0.3 mg in 30 mL AVOCADO OIL (UNII: 6VNO72PFC1) (AVOCADO OIL - UNII:6VNO72PFC1) AVOCADO OIL 0.3 mg in 30 mL Inactive Ingredients Ingredient Name Strength TETRASODIUM EDETATE DIHYDRATE (UNII: 3JGX4KKZ4A) PHENOXYETHANOL (UNII: HIE492ZZ3T) VITAMIN E POLYETHYLENE GLYCOL SUCCINATE (UNII: O03S90U1F2) GLYCERIN (UNII: PDC6A3C0OX) XANTHAN GUM (UNII: TTV12P4NEE) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:84785-0006-1 30 mL in 1 BOTTLE; Type 0: Not a Combination Product 10/01/2024 2 NDC:84785-0006-2 60 mL in 1 BOTTLE; Type 0: Not a Combination Product 10/01/2024 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M016 10/01/2024 Labeler - Gazebo Wellness SKIN LLC (119609953) Registrant - Gazebo Wellness SKIN LLC (119609953) Establishment Name Address ID/FEI Business Operations Gazebo Wellness SKIN LLC 119609953 manufacture(84785-0006)