NEXT GENERATION Correct Brightening Serum

NEXT GENERATION Correct Brightening Serum by

Drug Labeling and Warnings

NEXT GENERATION Correct Brightening Serum by is a Otc medication manufactured, distributed, or labeled by Pulsaderm LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

NEXT GENERATION CORRECT BRIGHTENING SERUM- hydroquinone solution 
Pulsaderm LLC

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.

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NEXT GENERATION Correct Brightening Serum

Drug Facts

Active Ingredient

Hydroquinone 2.00%

Purpose

Skin Lighterner

Uses

For gradual fading of hyperpigmentation of skin / dark spots such as freckles, age spots and liver spots.

Warnings:

For external use only

When using this product

Avoid contact with eyes or eyelids.

Some users of this product may experience mild skin irritation. Consult physician if skin irritation becomes severe.

Do not use 

On children under 12, unless directed by physician.

If pregnant or breast feeding,

ask a health professional before use.

Keep out of reach of children.

If swallowed, contact physician or poison control center immediately.

Directions

• Adults: Apply a thin layer on the affected areas twice daily, or as directed by physician. If no improvement is seen after three months of treatment, discontinue use of this product and consult physician. Lightening effect of this product may be less noticeable on very dark skin.
• Children under 1-2 years of age: Do not use this product unless directed by a physician.
• Sun exposure should be limited by using sunscreen agent, sun blocking agent, or protective clothing to cover bleached skin when using, and after using this product, in order to prevent darkening from reoccurring.

Inactive Ingredients:

Algae Extract, Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Ascorbic Acid (Vitamin C), Bis-Vinyl Dimethicone/Dimethicone Copolymer, Butylene Glycol, C12-15 Alkyl Benzoate, Caprylic/Capric Triglyceride, Cyclopentasiloxane, Diazolidinyl Urea, Glucosamine HCL, Glycerin, 1% Glycolic Acid, Glycyrrhiza Glabra (Licorice) Extract, Hydroxyethylcellulose, Isohexadecane, Kojic Acid, Methyl Paraben, Morus Alba (Mulberry) Extract, Polysorbate 80, Propyl Paraben, Propylene Glycol, Sodium Acryloyldimethyl Taurate Copolymer, Sodium Ascorbyl Phosphate (Vitamin C), Sodium Metabisulfite, Sodium PCA, Tetrasodium EDTA, Tocopheryl Acetate (Vitamin E), Urea, Vitis VInifera (Grape) Seed Extract, Yeast Extract.

Package Labeling:

NEXT GENERATION CORRECT BRIGHTENING SERUM 
hydroquinone solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71177-162
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HYDROQUINONE (UNII: XV74C1N1AE) (HYDROQUINONE - UNII:XV74C1N1AE)	HYDROQUINONE	20 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
WATER (UNII: 059QF0KO0R)
ASCORBIC ACID (UNII: PQ6CK8PD0R)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
GLUCOSAMINE HYDROCHLORIDE (UNII: 750W5330FY)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCOLIC ACID (UNII: 0WT12SX38S)
GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)
HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)
ISOHEXADECANE (UNII: 918X1OUF1E)
KOJIC ACID (UNII: 6K23F1TT52)
METHYLPARABEN (UNII: A2I8C7HI9T)
WHITE MULBERRY (UNII: MN25R0HH5A)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)
SODIUM METABISULFITE (UNII: 4VON5FNS3C)
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)
EDETATE SODIUM (UNII: MP1J8420LU)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
UREA (UNII: 8W8T17847W)
VITIS VINIFERA SEED (UNII: C34U15ICXA)
YEAST, UNSPECIFIED (UNII: 3NY3SM6B8U)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71177-162-15	1 in 1 BOX	06/16/2020	06/30/2021
1		15 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part358A	06/16/2020	06/30/2021

Labeler - Pulsaderm LLC (080429881)

Revised: 4/2022

Document Id: dcf2bc54-193a-7bb0-e053-2995a90a7726

34390-5

Set id: 1d398844-adfc-4324-a35c-6381191e4aa4

Version: 2

Effective Time: 20220418