Ala Quin Cream

Iodochlorhydroxyquin (Clioquinol) is an antifungal agent and a member of a family of drugs called hydroxyquinolines. Chemically, Iodochlorhydroxyquin is 5-chloro-7-iodo-quinolin-8-ol. Its structural formula is:

The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and antipruritic agents. Hydrocortisone is a member of this class. Chemically hydrocortisone is pregn-4-ene-3, 20-dione, 11, 17, 21-trihydroxy, (11β)-. Its structural formula is:

Each gram of ALA-QUIN contains 5 mg Hydrocortisone USP and 30 mg Iodochlorhydroxyquin USP in a cream base consisting of purified water, glycerin, cetyl alcohol, polysorbate 80, stearyl alcohol, sodium lauryl sulfate, cetyl palmitate and sorbic acid.

Based on a review of this drug by the National Academy of Sciences-National Research Council and/or other information, FDA has classified the indications as follows:

“Possibly” effective: Contact or atopic dermatitis; impetiginized eczema; nummular eczema; infantile eczema; endogenous chronic infectious dermatitis; stasis dermatitis; pyoderma; nuchal eczema and chronic eczematoid otitis externa; acne urticata; localized or disseminated neurodermatitis; lichen simplex chronicus; anogenital pruritus (vulvae, scroti, ani); folliculitis; bacterial dermatoses; mycotic dermatoses such as tinea (capitis, cruris, corporis, pedis); moniliasis; intertrigo.

Final classification of the less-than-effective indications requires further investigation.

The following tests may be helpful in evaluating the HPA axis suppression:

Urinary free cortisol test

ACTH stimulation test

Although topical steroids have not been reported to have an adverse effect on pregnancy, the safety of their use in pregnant women has not been absolutely established. Use of large amounts or for prolonged periods of time is not recommended since systemic absorption may occur. In laboratory animals, increases in incidence of fetal abnormalities have been associated with exposure of gestating females to topical corticosteroids, in some cases at rather low dosage levels. The more potent corticosteroids have been shown to be teratogenic after dermal application in laboratory animals. There are no adequate and well-controlled studies in pregnant women on teratogenic effects from topical applied corticosteroids. Topical corticosteroids should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Therefore, drugs of this class should not be used extensively on pregnant patients in large amounts or for prolonged periods of time.

NDC 0316-0123-01

Rx Only

ALA-QUIN ®

Hydrocortisone 0.5%

Iodochlorhydroxyquin 3% Cream

1 oz (28.4 grams)

WARNING: Keep out of reach of children.

For external use only. Not for ophthalmic use.

See crimp of tube for Lot Number and Expiration Date.

Each gram contains: 5 mg Hydrocortisone USP and 30 mg Iodochlorhydroxyquin USP in a cream base consisting of purified water, glycerin, cetyl alcohol, polysorbate 80, stearyl alcohol, sodium lauryl sulfate, cetyl palmitate and sorbic acid.

Usual Dosage: Apply as a thin film to the affected areas 2 to 4 times daily or as directed by physician. See package insert for full prescribing information.

TO OPEN: Use cap to puncture seal.

IMPORTANT: Do not use if seal has been punctured or is not visible.

Store at 20 o-25 oC (68 o-77 oF) [See USP Controlled Room Temperature].

Protect from freezing.

Manufactured and Distributed by:

Crown Laboratories, Inc.

Johnson City, TN 37604

P6501.03

NDC 0316-0123-01

Rx Only

ALA-QUIN ®

Hydrocortisone 0.5%

Iodochlorhydroxyquin 3% Cream

1 oz (28.4 grams)

WARNING: Keep out of reach of children.

For external use only.

Not for ophthalmic use.

Usual Dosage: Apply as a thin film to the affected areas 2 to 4 times daily or as directed by physician. See package insert for full prescribing information.

Each gram contains: 5 mg Hydrocortisone USP and 30 mg Iodochlorhydroxyquin USP in a cream base consisting of purified water, glycerin, cetyl alcohol, polysorbate 80, stearyl alcohol, sodium lauryl sulfate, cetyl palmitate and sorbic acid.

Directions for puncturing tube seal: Remove cap. Turn cap upside down and place puncture tip onto tube. Push cap until tube end is punctured. Screw cap back on to reseal tube.

Store at 20 o-25 oC (68 o-77 oF) [See USP Controlled Room Temperature]. Protect from freezing.

See end of carton for Lot Number and Expiration Date.

Manufactured and Distributed by:

Crown Laboratories, Inc.

Johnson City, TN 37604

P9003.01

Applies to clioquinol / hydrocortisone topical: topical cream, topical ointment

Along with its needed effects, clioquinol / hydrocortisone topical may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking clioquinol / hydrocortisone topical:

• Blistering, burning, crusting, dryness, or flaking of the skin
• burning and itching of the skin with pinhead-sized red blisters
• burning, itching, and pain in hairy areas, or pus at the root of the hair
• darkening of the skin
• diarrhea
• dizziness
• dryness
• fainting
• fast heartbeat
• fever
• hives, itching, or rash
• hoarseness
• irritation
• itching, scaling, severe redness, soreness, or swelling of the skin
• joint pain, stiffness, or swelling
• loss of appetite
• mental depression
• nausea
• reddish purple lines on the arms, face, legs, trunk, or groin
• redness and scaling around the mouth
• softening of the skin
• swelling of the eyelids, face, lips, hands, or feet
• thinning of the skin with easy bruising, especially when used on the face or where the skin folds together (eg, between the fingers)
• tightness in the chest
• troubled breathing or swallowing
• unusual tiredness or weakness
• vomiting

Some side effects of clioquinol / hydrocortisone topical may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Acne or pimples
• increased hair growth on the forehead, back, arms, and legs
• lightening of normal skin color
• lightening of the treated areas of dark skin

Caution is recommended. -According to some authorities: Benefit should outweigh risk. Excreted into human milk: Unknown Excreted into animal milk: Data not available Comments: -Only water-miscible creams or gels should be applied to the breast because ointments may expose the infant to high levels of mineral paraffins via licking. -Any product containing a topical corticosteroid should be wiped off thoroughly prior to nursing if it is being applied to the breast or nipple area.