ALPHAQUIN HP- hydroquinone, octinoxate and oxybenzone cream
Stratus Pharamceuticals
FOR EXTERNAL USE ONLY: NOT FOR OPHTHALMIC, NASAL OR OTIC USE.
DESCRIPTION
Each gram of ALPHAQUIN? HP 4% CREAM Contains: ACTIVE: 40 mg of Hydroquinone USP, 7.5% Octyl Methoxycinnamate,5.0% Benzophenone-3 in cream base of: INACTIVES: Purified Water, Propylene Glycol, Glycerine, Cetyl Alcohol, Cetostearyl Alcohol, Glycolic Acid, Isopropyl Palmitate, Stearyl Alcohol, Sodium Lauryl Sulfate, Sodium Metabisulfite, Citric Acid, Sorbic Acid and Sodium Hydroxide.
Hydroquinone is 1, 4-Benzenediol, with chemical formula of C6H6O2 and molecular weight of 110.11.
CLINICAL PHARMACOLOGY
Topical application of hydroquinone produces reversible depigmentation of the skin by the inhibition of the enzymatic oxidation of tyrosine to 3, 4-dihydroxyphenylalanine (DOPA) [Denton, C., et al., 1952 ] and suppression of other melanocyte metabolic processes [Jimbow, K., et al., 1974 ]. Exposure to sunlight or ultraviolet light will cause repigmentation of the bleached areas [Parrish, J.A. et al., 1978 ].
Alphaquin HP Indications and USAge
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.
Pregnancy Category C
DOSAGE AND ADMINISTRATION
ALPHAQUIN? HP 4% CREAM should be applied to affected areas twice daily, in the morning and before bedtime, or as directed by physician. Unnecessary solar exposure should be avoided. There is no recommended dosage for children under 12 years of age except under the advice and supervision of physician. Keep container tightly closed. NOTE: Slight darkening of ALPHAQUIN? HP 4% CREAM is normal and does not affect potency of the product.
HOW SUPPLIED
ALPHAQUIN? HP 4% CREAM (Hydroquinone, USP 4%) is supplied as follows:
SIZE
NDC NUMBER
1 oz tube (28.4 grams)
58980-580-10
2 oz tube (56.7 grams)
58980-580-20
STORAGE
Store at 20?C to 25?C (68?F to 77?F), excursions permitted between 15?C and 30?C (between 59?F and 86?F). Brief exposure to temperatures up to 40?C (104?F) may be tolerated provided the mean kinectic temperature does not exceed 25?C (77?F); however, such exposure should be minimized. [See USP Controlled Room Temperature]. Protect from freezing. If freezing occurs, warm to room temperature.
Keep out of the reach of children.