NIACINAMIDE B3 SERUM solution

Niacinamide B3 Serum by

Drug Labeling and Warnings

Niacinamide B3 Serum by is a Otc medication manufactured, distributed, or labeled by Gazebo Wellness SKIN LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DOSAGE & ADMINISTRATION

Niacinamide 83 Serum helps to protect the skin's immune function as well as improve signs of sun damage, dryness and roughness.

WARNINGS

Directions: Apply a small amount twice daily to the affected area. Make sure skin is clean and dry. Gently massage until completely absorbed.

INACTIVE INGREDIENT

Inactive ingredients: Glycerin, Emulsifying Wax NF, Phenoxyethanol, Xanthan Gum, Tetrasodium EDTA.

ACTIVE INGREDIENT

Active ingredients: Aloe Vera Leaf Juice, Niacinamide (Vitamin B3), Avocado Oil, Vitamin E, Organic Neem Seed Oil, Rosemary Leaf Extract, Hyaluronic Acid.

INDICATIONS & USAGE

Apply a small amount twice daily to the affected area. Make sure skin is clean and dry. Gently massage until completely absorbed.

KEEP OUT OF REACH OF CHILDREN

keep out of reach of children

PURPOSE

natural + organic Niacinamide B3 facial serum
Niacinamide 83 Reduces Water Loss in the Skin and Retains Fatty Acid Levels for a Younger, Plumper and Firmer Skin.

Distributed By: Skin Beauty Solutions Elk Grove CA 95759

PRINCIPAL DISPLAY PANEL

Content of labeling

INGREDIENTS AND APPEARANCE

NIACINAMIDE B3 SERUM 
niacinamide b3 serum solution

Product 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)