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ADVANCED SKIN LIGHTENING CREAM- hydroquinone lotion


  1. Purpose
  2. Indications & Usage
  3. Dosage & Administration
  4. Active Ingredient
  5. Description
  6. Contraindications
  7. Warnings And Precautions
  8. Keep Out Of Reach Of Children
  9. Directions
  10. How Supplied
  11. Inactive Ingredients
  12. Principal Display Panel

Purpose 

Skin Bleaching and Correcting

Indications & Usage 

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 

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

Active Ingredient 

Hydroquinone

Description 

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 

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 

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 

Advanced Skin Lightening Cream should be kept away from Children.

Directions 

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 

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

Inactive Ingredients 

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 

Advanced Skin Lightening Cream_Carton LabelAdvanced Skin Lightening Cream_Carton Label

ADVANCED SKIN LIGHTENING CREAM
hydroquinone lotion
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:67226-2821
Route of Administration TOPICAL
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HYDROQUINONE (UNII: XV74C1N1AE) (HYDROQUINONE - UNII:XV74C1N1AE) HYDROQUINONE 2 g in 100 mL
Inactive Ingredients
Ingredient Name Strength
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
BUTYLPARABEN (UNII: 3QPI1U3FV8)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CETYL ALCOHOL (UNII: 936JST6JCN)
EDETATE DISODIUM (UNII: 7FLD91C86K)
DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)
GLYCERIN (UNII: PDC6A3C0OX)
LACTIC ACID (UNII: 33X04XA5AT)
ASCORBIC ACID (UNII: PQ6CK8PD0R)
METHYLPARABEN (UNII: A2I8C7HI9T)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
PPG-2 MYRISTYL ETHER PROPIONATE (UNII: 88R97D8U8A)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
SODIUM CETOSTEARYL SULFATE (UNII: 7ZBS06BH4B)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
SODIUM METABISULFITE (UNII: 4VON5FNS3C)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
WATER (UNII: 059QF0KO0R)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:67226-2821-6 1 in 1 BOX
1 60 mL in 1 TUBE; 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 06/01/2016
Labeler - Vivier Pharma, Inc. (250996550)
Establishment
Name Address ID/FEI Business Operations
Vivier Pharma, Inc. 250996550 manufacture(67226-2821)

Revised: 12/2015 Vivier Pharma, Inc.



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