ULTRA-POTENT BRIGHTENING SERUM- hydroquinone gel

Ultra-Potent Brightening Serum by

Drug Labeling and Warnings

Ultra-Potent Brightening Serum by is a Otc medication manufactured, distributed, or labeled by Velocity Production and Packaging, CoValence, CoValence Laboratories. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

ACTIVE INGREDIENT(S):

Hydroquinone........... 2%

Purpose

PURPOSE:

Skin Lightener

Uses

USES:

For the gradual fading of hyperpigmentation spots

Warnings

WARNINGS:

When Using

When uisng this product avoid contact with eyes. Some users of this product may experience a mild skin irritation.

Stop Use

Stop use and ask a doctor if skin irritation becomes severe.

Keep out

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Sun Alert

SUN ALERT:

The Alpha and Beta Hydroxy Acids (AHA/BHA) in this product may increase sun sensitivity.

Wear sunscreen or protective clothing during use to protect against sunburn and for a week afterwards. Continue sun protection after the lightening regimen to avoid UV-induced pigmentations.

Dosage & Administration

Adults: apply a small amount as a thin layer on the affected area once or twice daily, or use as directed by a doctor. Do not use on or around the eye area.

Directions

DIRECTIONS:

• If no improvement is seen after 3 months of treatment, use of this product should be discontinued. Lightning effect of this product may not be noticable when used on very dark skin.
• Children under 12 years of age: do not use unless directed by a doctor.
• Sun exposure should be limited by using a sunscreen agent, or protective clothing to cover bleached skin when using and after using this product in order to prevent darkening from reoccuring.

Inactive ingredients

INACTIVE INGREDIENTS:

Propylene Glycol, Alcohol Denat., Azelaic Acid, Aqua (Water), Hamamelis Virginiana (Witch Hazel) Water, Lactic Acid (L), Kojic Acid, Salicylic Acid, Alcohol, Ascorbic Acid (L), Hydroxypropyl Methylcellulose, Sodium Hydroxide

Questions or comments?

Questions or comments?

Admire My Skin, 340 Royal Poinciana Way #317-356, Palm Beach FL 33480

www.admiremyskin.com

Principal display panel and carton images

Principal display panel

First accordion label, beneath the principal display panel

Second accordion label, beneath the principal display panel

Outer carton

INGREDIENTS AND APPEARANCE

ULTRA-POTENT BRIGHTENING SERUM 
hydroquinone gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72591-4832
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HYDROQUINONE (UNII: XV74C1N1AE) (HYDROQUINONE - UNII:XV74C1N1AE)	HYDROQUINONE	0.2 g  in 10 mL

Inactive Ingredients
Ingredient Name	Strength
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SALICYLIC ACID (UNII: O414PZ4LPZ)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
HAMAMELIS VIRGINIANA LEAF WATER (UNII: 8FP93ED6H2)
LACTIC ACID, L- (UNII: F9S9FFU82N)
KOJIC ACID (UNII: 6K23F1TT52)
ASCORBIC ACID (UNII: PQ6CK8PD0R)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
ALCOHOL (UNII: 3K9958V90M)
DISODIUM AZELATE (UNII: 0P4H8NH3UJ)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color	yellow (Pale)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72591-4832-1	1 in 1 CARTON	02/11/2019
1		30 mL in 1 BOTTLE, PUMP; 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	10/26/2018

Labeler - Velocity Production and Packaging (081076893)

Registrant - CoValence (959735002)

Establishment
Name	Address	ID/FEI	Business Operations
Velocity Production and Packaging		081076893	pack(72591-4832)

Establishment
Name	Address	ID/FEI	Business Operations
CoValence Laboratories		959735002	manufacture(72591-4832)