FDA.reportPublic FDA data

Dr. Lightening Ultra-Potent Facial Cream

Manufacturer
Clinical Resolution Laboratory, Inc.
Effective date
2019-04-30
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-02 00:24:42

Label at a glance#

ProductDr. Lightening Ultra-Potent Facial
Active ingredientHYDROQUINONE
Label structure8 sections

Indications and uses

for the gradual fading of hyperpigmentation spots.

Dosage and administration

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 prot...

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Hydroquinone 2%

Purpose

OTC - PURPOSE SECTION

Skin Lightener

Uses:

INDICATIONS & USAGE SECTION

for the gradual fading of hyperpigmentation spots.

Warnings:

WARNINGS SECTION

For external use only

When using this product

OTC - WHEN USING SECTION

  • 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.

OTC - STOP USE SECTION

  • if skin irritation becomes severe.

if pregnant or breastfeeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

  • consult a doctor before use.

Do not use this product if

OTC - DO NOT USE SECTION

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

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DOSAGE & ADMINISTRATION SECTION

  • 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

SPL UNCLASSIFIED SECTION

store at 20°-25° C (68-77° F)

Inactive Ingredients

INACTIVE INGREDIENT SECTION

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?

OTC - QUESTIONS SECTION

Call toll free 1(844) 694-0004

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 27 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
63742-02563742-025-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 26 matching rows.

Name, UNII, Kind table
NameUNIIKind
MAGNESIUM ALUMINUM SILICATE6M3P64V0NCIACT
TEA TREE OILVIF565UC2GIACT
NIACINAMIDE25X51I8RD4IACT
PEG-100 STEARATEYD01N1999RIACT
PHENOXYETHANOLHIE492ZZ3TIACT
WATER059QF0KO0RIACT
SALICYLIC ACIDO414PZ4LPZIACT
SODIUM BENZOATEOJ245FE5EUIACT
SODIUM SULFITEVTK01UQK3GIACT
TRIDECETH-63T5PCR2H0CIACT
HYDROQUINONEXV74C1N1AEACTIB
ARBUTINC5INA23HXFIACT
ARGININE94ZLA3W45FIACT
AZELAIC ACIDF2VW3D43YTIACT
CARRAGEENAN5C69YCD2YJIACT
POLYOXYL 20 CETOSTEARYL ETHERYRC528SWUYIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
CYCLOMETHICONE 50THT5PCI0RIACT
DIMETHYL ISOSORBIDESA6A6V432SIACT
EDETATE DISODIUM ANHYDROUS8NLQ36F6MMIACT
GLYCERINPDC6A3C0OXIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
HYDROGENATED POLYDECENE (550 MW)U333RI6EB7IACT
ISODODECANEA8289P68Y2IACT
KOJIC ACID6K23F1TT52IACT

Source Document#

Source XML · Source PDF

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
87be89b9-81fc-5e5c-e053-2995a90a3f18028c092f-c29d-4e59-8bd3-f5848849fbe92019-04-30WarningsExact identifier
spl id: 87be89b9-81fc-5e5c-e053-2995a90a3f18
spl set id: 028c092f-c29d-4e59-8bd3-f5848849fbe9

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.