Alphaquin HP Cream

Name: Alphaquin HP Cream

Alphaquin HP Cream - Clinical Pharmacology

Topical application of hydroquinone produces a reversible depigmentation of the skin by the inhibition of the enzymatic oxidation of tyrosine to 3, 4-dihydroxyphenylalanine (DOPA) [Denton, C., et al., 1952 (1)] and suppression of other melanocyte metabolic processes [Jimbow, K., et al., 1974 (2)]. Exposure to sunlight or ultraviolet light will cause repigmentation of the bleached areas [Parrish, J.A. et al., 1978 (3)].

Indications and Usage for Alphaquin HP Cream

ALPHAQUIN® HP 4% CREAM is indicated for the gradual bleaching of hyperpigmented skin conditions such as chloasma, melasma, freckles, senile lentigines and other undesired areas of melanin hyperpigmentation.

Contraindications

ALPHAQUIN® HP 4% CREAM is contraindicated in persons who have shown hypersensitivity to hydroquinone or any of the other ingredients. The safety of topical treatment of hydroquinone during pregnancy or in children (12 years and under) has not been established. (See PRECAUTIONS).

Hydroquinone references

  1. Denton, C., Lerner, A., and Fitzpatrick, T., "Inhibition of Melanin Formation by Chemical Agents", J. Invest. Derm., 18:119-135, 1952.
  2. Jimbow, K., Obata, M., Pathak, M., and Fitzpatrick, T., "Mechanisms of Depigmentation by Hydroquinone" J. Invest. Derm., 62:436-449, 1974.
  3. Parrish, J, Anderson, R., Urbach, F., and Pitts, D., " Biological Effects of Ultraviolet Radiation with Emphasis on Human Responses to Longwave Ultraviolet", Plenum Press, New York, 1978 (page 151).

Rev. JG-ACI 2012-304

PRINCIPAL DISPLAY PANEL - 28.4 g Tube Carton

NDC 58980-580-10
Net WT. 1 OZ (28.4g)

ALPHAQUIN® HP 4% CREAM
STRATUS
PHARMACEUTICALS INC

(HYDROQUINONE USP, 4%)

SKIN BLEACHING CREAM WITH SUNSCREENS

Rx only

Distributed by Stratus Pharmaceuticals Inc., 12379 SW 130th Street, Miami, Florida 33186

ALPHAQUIN HP 
hydroquinone, octinoxate, and oxybenzone cream
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:58980-580
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Hydroquinone (Hydroquinone) Hydroquinone 40 mg  in 1 g
Octinoxate (Octinoxate) Octinoxate 75 mg  in 1 g
Oxybenzone (Oxybenzone) Oxybenzone 50 mg  in 1 g
Inactive Ingredients
Ingredient Name Strength
Water  
Propylene Glycol  
Glycerin  
Cetyl Alcohol  
Cetostearyl Alcohol  
Glycolic Acid  
Isopropyl Palmitate  
Stearyl Alcohol  
Sodium Lauryl Sulfate  
Sodium Metabisulfite  
Citric Acid Monohydrate  
Sorbic Acid  
Sodium Hydroxide  
Product Characteristics
Color WHITE Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description
1 NDC:58980-580-20 1 TUBE in 1 BOX
1 56.7 g in 1 TUBE
2 NDC:58980-580-10 1 TUBE in 1 BOX
2 28.4 g in 1 TUBE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
UNAPPROVED DRUG OTHER 01/01/1993
Labeler - Stratus Pharamceuticals (789001641)
Establishment
Name Address ID/FEI Operations
Sonar Products Inc 104283945 MANUFACTURE(58980-580)
Revised: 11/2012   Stratus Pharamceuticals

For Healthcare Professionals

Applies to hydroquinone topical: compounding powder, topical cream, topical emulsion, topical gel, topical solution

Dermatologic

Dermatologic side effects have included localized contact dermatitis. Exogenous ochronosis (involving over 10,000 exposures under careful clinical supervision) has been reported at an incidence of 22 cases in more than 50 years.[Ref]

Some side effects of hydroquinone topical may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

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