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Nuquin HP Cream

Generic Name: hydroquinone
Dosage Form: cream

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

NUQUIN® HP 4% CREAM
(HYDROQUINONE 4% USP)

SKIN BLEACHING TOPICAL CREAM WITH SUNSCREENS

Rx only

FOR EXTERNAL USE ONLY: NOT FOR OPHTHALMIC, NASAL, OR OTIC USE.

Nuquin HP Cream Description

Each gram of NUQUIN® HP 4% CREAM contains ACTIVES: 40mg Hydroquinone USP, 80mg of Padimate O, 30mg of Dioxybenzone and 20mg of Oxybenzone in a cream base of INACTIVES: Cetostearyl Alcohol, Glycerine, Mineral Oil, Polysorbate-60, Propylene Glycol, Purified Water, Sodium Lauryl Sulfate, Sodium Metabisulfite, Sorbic Acid and White Petrolatum.

Hydroquinone is 1, 4-Benzenediol. Hydroquinone is structurally related to monobenzone. Hydroquinone occurs as fine, white needles. The drug is freely soluble in water and in alcohol and has a pKa of 9.96. Chemically, hydroquinone is designated as p-dihydroxybenzene; the empirical formula is C6H6O2 and has a molecular weight of 110.11.

The structural formula is:

C6H602

Nuquin 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., 19521] and suppression of other melanocyte metabolic processes [Jimbow, K., et al., 19742]. Exposure to sunlight or ultraviolet light will cause repigmentation of the bleached areas [Parrish, J.A. et al., 1978].

Indications and Usage for Nuquin HP Cream

NUQUIN® 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

NUQUIN® 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).

Warnings

1. Hydroquinone is a skin bleaching agent which may produce undesired effects if not used as directed. The physician should be familiar with the contents of this insert before prescribing or dispensing this medication.

2. To evaluate possible susceptibility to irritation or sensitivity, each patient should begin by applying the medication to a small portion of unbroken skin at or near the pigmented area over a period of several days. Minor redness is not necessarily a contraindication, but treatment should be discontinued if itching, excessive inflammation or vesicle formation occurs. Use of NUQUIN® HP 4% CREAM in paranasal and infraorbital areas increases the chance of irritations (See ADVERSE REACTIONS). If no improvement is seen after two months of treatment, use of this product should be discontinued.

3. Sunscreen use is an essential aspect of the hydroquinone therapy because even minimal sunlight exposure sustains melanocytic activity. The sunscreens in NUQUIN® HP 4% CREAM provide the necessary sun protection during the process of skin bleaching. After clearing and during the maintenance period of therapy, sun exposure should be avoided on the bleached skin by the application of a suncreen or a sunblock agent, or protective clothing to prevent the skin from repigmenting.

4. Contains Sodium Metabisulfite, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Sulfite sensitivity is seen more frequently in asthmatic than in nonasthmatic people.

5. Keep this and all other medications out of reach of children. In case of accidental ingestion, call a physician or a poison control center immediately.

6. Avoid contact with eyes. In case of accidental contact, patient should rinse eyes thoroughly with water and contact a physician.

A bitter taste and antiseptic effect may occur if applied to the lips.

Precautions

(SEE WARNINGS)

Pregnancy Category C

Animal reproduction studies have not been conducted with hydroquinone. It is also not known whether hydroquinone can cause fetal harm when administered on a pregnant woman or can affect reproductive capacity. It is also not known to what degree, if any, topical hydroquinone is absorbed systemically. Topical hydroquinone should be used in pregnant women only when clearly indicated.

Nursing Mothers

It is not known whether topical administration of hydroquinone is absorbed or excreted in human milk. Because many drugs are excreted in human milk, caution is advised when topical hydroquinone is administered to a nursing woman.

Pediatric Use

Safety and effectiveness in children below the age of 12 years has not been established.

Adverse Reactions

No systemic adverse reactions have been reported. Occasional hypersensitivity (localized contact dermatitis) may occur in which case the medication should be discontinued and the physician notified immediately.

Overdosage

There have been no systemic reactions reported from the use of topical hydroquinone treatment. However, treatment should be limited to relatively small areas of the body at one time since some patients may experience a transient skin reddening and a mild burning sensation which does not preclude treatment.

Nuquin HP Cream Dosage and Administration

NUQUIN® HP 4% CREAM should be applied to affected areas twice daily, in the morning and before bedtime or as directed by a 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 a physician. Keep container tightly closed. NOTE: Slight darkening of NUQUIN® HP 4% CREAM is normal and does not affect potency of the product.

How is Nuquin HP Cream Supplied

NUQUIN® HP 4% CREAM (Hydroquinone 4%) is supplied as follows:

SIZE NDC NUMBER
1 oz tube (28.4 grams) 58980-574-10
2 oz tube (56.7 grams) 58980-574-20

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 kinetic 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. In case of accidental ingestion, call a physician or poison control center immediately.

Manufactured by:
Sonar Products, Inc.
Carlstadt, NJ 07072

Exclusively for:
STRATUS PHARMACEUTICALS INC
12379 SOUTHWEST 130TH STREET
MIAMI, FLORIDA 33186

Customer Service
Telephone: 1-800-442-7882
Fax: 305-254-6875

Copyright ©1993 Stratus Pharm., Inc.
All rights reserved.

Rvsd. JG-NCI-2014-084

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).

PRINCIPAL DISPLAY PANEL - 28.4 g Tube Box

NDC 58980-574-10
Net WT. 1 OZ (28.4g)

NUQUIN® 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

NUQUIN HP 
hydroquinone, padimate o, dioxybenzone, and oxybenzone cream
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:58980-574
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Hydroquinone (Hydroquinone) Hydroquinone 40 mg  in 1 g
Padimate O (Padimate O) Padimate O 80 mg  in 1 g
Dioxybenzone (Dioxybenzone) Dioxybenzone 30 mg  in 1 g
Oxybenzone (Oxybenzone) Oxybenzone 20 mg  in 1 g
Inactive Ingredients
Ingredient Name Strength
Water  
GLYCERIN  
PETROLATUM  
CETOSTEARYL ALCOHOL  
SORBIC ACID  
Mineral Oil  
POLYSORBATE 60  
SODIUM LAURYL SULFATE  
SODIUM METABISULFITE  
PROPYLENE GLYCOL  
Product Characteristics
Color YELLOW (Light) Score     
Shape Size
Flavor Imprint Code
Contains         
Packaging
# Item Code Package Description
1 NDC:58980-574-10 1 TUBE in 1 BOX
1 28.4 g in 1 TUBE
2 NDC:58980-574-20 1 TUBE in 1 BOX
2 56.7 g in 1 TUBE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
UNAPPROVED DRUG OTHER 12/09/2003
Labeler - Stratus Pharmaceuticals (789001641)
Establishment
Name Address ID/FEI Operations
Sonar Products, Inc. 104283945 MANUFACTURE(58980-574)
Revised: 11/2014
 
Stratus Pharmaceuticals
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