Advanced Skin Lightening Cream

Manufacturer
Vivier Pharma, Inc.
Effective date
2015-12-15
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 01:26:27

Label at a glance#

ProductAdvanced Skin Lightening Cream
Active ingredientHYDROQUINONE
Label structure12 sections

Dosage and administration

Test for skin sensitivity before using by applying Advanced Skin Lightening Cream to an area of unbroken skin about 25 mm in diameter. If excessive irritation, rash or other reaction develops within 24 hours, discontinue use. Use fingertips to apply a thin layer to the affected areas. Use both morning and night or as directed by a physician. Depigmentation is a gradual process and results should be expected within...

Label contents#

Full prescribing information#

PURPOSE

OTC - PURPOSE SECTION

Skin Bleaching and Correcting

INDICATIONS & USAGE

INDICATIONS & USAGE SECTION

To gradually lighten hyperpigmentation of the skin such as age spots, liver spots, freckles or hyperpigmentation that can occur as a result of pregnancy or from the use of oral contraceptives.

DOSAGE & ADMINISTRATION

DOSAGE & ADMINISTRATION SECTION

Use fingertips to apply a thin layer to the affected areas. Use both morning and night or as directed by a physician.

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

Hydroquinone

DESCRIPTION

DESCRIPTION SECTION

Each gram of Advanced Skin Lightening Cream contains 20 mg/g Hydroquinone USP in a nonmedicinal cream base of Butylated Hydroxy Toluene, Butylparaben, Cetearyl Alcohol, Cetyl Alcohol, Disodium EDTA, Ethoxydiglycol, Fragrance, Glycerin, Lactic Acid, L-Ascorbic Acid USP, Methylparaben, Phenyl Trimethicone, PPG-2 Myristyl Ether Propionate, Propylparaben, Sodium Cetearyl Sulfate, Sodium Lauryl Sulfate, Sodium Metabisulfite, Tocopheryl Acetate, Water/Eau.

CONTRAINDICATIONS

CONTRAINDICATIONS SECTION

Prior history of sensitivity or allergic reaction to this product or any of its ingredients. The safety of topical Hydroquinone use during pregnancy or in children (12 years and under) has not been established.

WARNINGS AND PRECAUTIONS

WARNINGS SECTION

For external use only. Use only on the advice of a physician. A mild transient stinging may occur for people with sensitive skin. Do not use on broken or irritated skin. Discontinue use if irritation or rash occurs. Avoid contact with eyes and mucous membranes. In case of contact, rinse thoroughly with water. Do not use on children under 12 years of age. Keep out of reach of children. Avoid usage around the eyes and lips. Contains Sodium Metabisulfite, a sulfite that may cause allergic-type reactions (hives, itching, wheezing, anaphylaxis, severe asthma attacks) in certain susceptible persons. Do not use this product if you are pregnant or nursing unless instructed by a physician.

KEEP OUT OF REACH OF CHILDREN

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Advanced Skin Lightening Cream should be kept away from Children.

DIRECTIONS

INSTRUCTIONS FOR USE SECTION

Test for skin sensitivity before using by applying Advanced Skin Lightening Cream to an area of unbroken skin about 25 mm in diameter. If excessive irritation, rash or other reaction develops within 24 hours, discontinue use. Use fingertips to apply a thin layer to the affected areas. Use both morning and night or as directed by a physician. Depigmentation is a gradual process and results should be expected within 12 weeks of daily use. To maintain results, use several times a week. If no improvement is seen within 8 weeks of regular use, discontinue use. Limit sun exposure during treatment by using protective clothing or a sunscreen protective agent to avoid re-darkening of the skin. Close cap securely after each use. Store at room temperature (15-30°C / 59-86°F).

HOW SUPPLIED

HOW SUPPLIED SECTION

ADVANCED SKIN LIGHTENING CREAM is available as follows: 60 mL / 2 fl oz.

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

Butylated Hydroxy Toluene, Butylparaben, Cetearyl Alcohol, Cetyl Alcohol, Disodium EDTA, Ethoxydiglycol, Fragrance, Glycerin, Lactic Acid, L-Ascorbic Acid USP, Methylparaben, Phenyl Trimethicone, PPG-2 Myristyl Ether Propionate, Propylparaben, Sodium Cetearyl Sulfate, Sodium Lauryl Sulfate, Sodium Metabisulfite, Tocopheryl Acetate, Water/Eau.

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Advanced Skin Lightening Cream_Carton LabelAdvanced Skin Lightening Cream_Carton LabelAdvanced Skin Lightening Cream_Carton Label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
67226-2821-62020-02-14C16284748780-19d75b9d0-ac6f-f424-e053-dadaa90a57ceAdvanced Skin Lightening Cream
67226-2821-62020-01-31C16284748780-19d75b9d0-ac6f-f424-e053-dadaa90a57ceAdvanced Skin Lightening Cream

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NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
67226-282167226-2821-6

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 19 matching rows.

Source Document#

Source XML

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
b2bfcf58-8e4e-479f-b22f-c66b47e9c97ae687c026-9cee-4b89-9bd9-51f010c876b52015-12-15WarningsExact identifier
spl id: b2bfcf58-8e4e-479f-b22f-c66b47e9c97a
spl set id: e687c026-9cee-4b89-9bd9-51f010c876b5

Reported adverse events (FAERS/openFDA)#

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