DR. LIGHTENING ULTRA-POTENT FACIAL- hydroquinone cream

Dr. Lightening Ultra-Potent Facial by

Drug Labeling and Warnings

Dr. Lightening Ultra-Potent Facial by is a Otc medication manufactured, distributed, or labeled by Clinical Resolution Laboratory, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DRUG FACTS

Active Ingredient

Hydroquinone 2%

Purpose

Skin Lightener

Uses:

for the gradual fading of hyperpigmentation spots.

Warnings:

For external use only

When using this product

• avoid contact with eyes.
• some users of this product may experience mild irritation. If skin irritation becomes severe, stop use and consult a doctor.
• for external use only.

for external use only.

• if skin irritation becomes severe.

if pregnant or breastfeeding,

• consult a doctor before use.

Do not use this product if

children under 12 years of age, unless directed by a doctor

Keep out of reach of children

if swallowed, get medical help or contact a Poison Control Center right away.

Sunburn 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.

Directions

• Adults: apply a small amount as a thin layer on the affected area twice daily, or use as directed by a doctor.
• Do not use on or around the eye area.
• If no improvement is seen after 3 months of treatment, use of this product should be discontinued. Lightening effect of this product may be noticeable when used on very dark skin.
• Sun exposure should be limited by using a sunscreen agent, a sun blocking agent, or protective clothing to cover bleached skin when using and after using this product in order to prevent darkening from reoccurring.

Other Information

store at 20°-25° C (68-77° F)

Inactive Ingredients

Arbutin, Arginine, Azelaic Acid, Carrageenan, Ceteareth-20, Cetearyl Alcohol, Citric Acid, Cyclopentasiloxane, Dimethyl Isosorbide, Disodium EDTA, Fragrance, Glycerin, Glyceryl Stearate, Hydrogenated Polydecene, Isododecane, Kojic Acid, Magnesium Aluminum Silicate, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Niacinamide, PEG-100 Stearate, Phenoxyethanol, Purified Water, Salicylic Acid, Sodium Benzoate, Sodium  Polyacrylate, Sodium Sulfite, Trideceth-6

Questions or comments?

Call toll free 1(844) 694-0004

Package Labeling:

INGREDIENTS AND APPEARANCE

DR. LIGHTENING ULTRA-POTENT FACIAL 
hydroquinone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63742-025
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 g

Inactive Ingredients
Ingredient Name	Strength
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)
TEA TREE OIL (UNII: VIF565UC2G)
NIACINAMIDE (UNII: 25X51I8RD4)
PEG-100 STEARATE (UNII: YD01N1999R)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
WATER (UNII: 059QF0KO0R)
SALICYLIC ACID (UNII: O414PZ4LPZ)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM SULFITE (UNII: VTK01UQK3G)
TRIDECETH-6 (UNII: 3T5PCR2H0C)
ARBUTIN (UNII: C5INA23HXF)
ARGININE (UNII: 94ZLA3W45F)
AZELAIC ACID (UNII: F2VW3D43YT)
CARRAGEENAN (UNII: 5C69YCD2YJ)
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
DIMETHYL ISOSORBIDE (UNII: SA6A6V432S)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
HYDROGENATED POLYDECENE (550 MW) (UNII: U333RI6EB7)
ISODODECANE (UNII: A8289P68Y2)
KOJIC ACID (UNII: 6K23F1TT52)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63742-025-01	44 g in 1 TUBE; Type 0: Not a Combination Product	02/15/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part358A	02/15/2019

Labeler - Clinical Resolution Laboratory, Inc. (825047942)