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KERYDIN® Indication and Important Safety Information

Pandel® Cream Indication and Important Safety Information

OXISTAT® Cream and Lotion Indication and Important Safety Information

VEREGEN® Indication and Important Safety Information

ApexiCon® E Cream Indication and Important Safety Information

 

KERYDIN® Indication

KERYDIN® is a topical prescription medicine used to treat fungal infections of the toenails.

Important Safety Information

KERYDIN® is for use on toenails only. Do not use KERYDIN® in your mouth, eyes, or vagina.

Tell your doctor about all of your medical conditions, including if you are pregnant or plan to become pregnant or are breastfeeding or plan to breastfeed. It is not known if KERYDIN® can harm your unborn baby or if KERYDIN® passes into your breast milk. It is not known if KERYDIN® is safe and effective in children.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Use KERYDIN® exactly as your healthcare provider tells you to use it. Avoid getting KERYDIN® on skin that is not surrounding the treated toenail. KERYDIN® is flammable. Avoid heat and flame while applying KERYDIN® to your toenail.

KERYDIN® may cause irritation at the treated site. The most common side effects include skin peeling, ingrown toenail, redness, itching, and swelling. Tell your doctor if you have any side effect that bothers you or does not go away.

Please see link to Full Prescribing Information below.

KERYDIN® (tavaborole) Topical Solution, 5% Full Prescribing Information

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.FDA.gov/medwatch or call 1-800-FDA-1088.

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PANDEL® Cream Indication

PANDEL® (hydrocortisone probutate) Cream, 0.1% is a topical prescription medication for the relief of the inflammatory (redness) and pruritic (itching) manifestations of corticosteroid-responsive skin conditions in patients 18 years of age or older.

Important Safety Information

This medication is for topical use only. Avoid contact with the eyes. The treated skin area should not be bandaged or otherwise covered or wrapped, unless directed by the physician. Therapy should be stopped when your condition gets better. If no improvement is seen within two weeks, contact the physician.

PANDEL can pass through your skin and cause adrenal gland problems. This is more likely to happen if you use PANDEL for too long, use it with other medicines that contain corticosteroids, apply it on a large area of your skin or apply it on broken skin, cover the treated area, have liver failure, or use it in pediatric patients. Your healthcare provider may do blood tests to check your adrenal gland function during and after treatment with PANDEL. Various hormonal abnormalities, increased blood sugar, and revealing underlying diabetes mellitus can also result from topical corticosteroids passing through your skin. Pediatric patients may be more susceptible to systemic toxicity.

Allergic contact dermatitis (rash) with corticosteroids is usually identified by a failure to heal rather than worsening of the condition, as seen with most topical products not containing corticosteroids. If irritation develops, discontinue PANDEL and institute appropriate therapy.

If you are pregnant or nursing a baby, consult with your physician prior to using this product.

The most frequent adverse reactions include burning, stinging, rash, red, bumpy rash, redness, itching, moderate tingling or prickling feeling, and allergic rash. Local adverse reactions that have been reported with topical corticosteroids include itching, irritation, dryness, folliculitis (swelling of the hair follicles), hypertrichosis (excessive hair growth), acneiform eruptions (acne or rashes resembling acne), hypopigmentation (loss of skin color), perioral dermatitis (rash around the mouth), allergic contact dermatitis (rash), secondary infections, skin atrophy (thinning), striae (lines on the skin), and miliaria (rash due to blocking of the sweat glands, ‘prickly heat’).

Please see the link to the Full Prescribing Information below.

Pandel® (hydrocortisone probutate) Cream, 0.1% Full Prescribing Information

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.FDA.gov/medwatch or call 1-800-FDA-1088.

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OXISTAT® Cream and Lotion Indication

OXISTAT® Cream and OXISTAT® Lotion are indicated for the topical treatment of the following dermal infections: tinea pedis, tinea cruris, and tinea corporis due to Trichophyton rubrum, Trichophyton mentagrophytes, or Epidermophyton floccosum. OXISTAT® Cream is indicated for the topical treatment of tinea (pityriasis) versicolor due to Malassezia furfur.

OXISTAT® Cream may be used in pediatric patients for tinea corporis, tinea cruris, tinea pedis, and tinea (pityriasis) versicolor; however, these indications for which OXISTAT® Cream has been shown to be effective rarely occur in children below the age of 12.

Important Safety Information

Do not use OXISTAT® Cream and Lotion if you have hypersensitivity to any ingredient of this product.

Use the product only externally. OXISTAT® is not to be used in the eyes or vagina. Avoid contact with the eyes, nose, mouth, and other mucous membranes. Do not cover the treated area unless directed otherwise by your physician.

Use the medication for the full treatment time recommended by your physician, even though symptoms may have improved.

Inform the physician if the area of application shows signs of increased irritation, itching, burning, blistering, swelling, or oozing. In clinical studies with OXISTAT®, the most commonly reported side effects were itching and burning.

If you are pregnant or nursing a baby, consult with your physician prior to using this product. For more information, consult your physician.

Please see the link to the Full Prescribing Information below.

OXISTAT® (oxiconazole nitrate) Cream, 1% & Lotion, 1% Full Prescribing Information

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.FDA.gov/medwatch or call 1-800-FDA-1088.

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VEREGEN® Indication

VEREGEN® is indicated for the topical treatment of external genital and perianal warts (Condylomata acuminata) in immunocompetent patients 18 years and older.

Important Safety Information

Do not use VEREGEN® Ointment, 15% if you are allergic to any ingredient in this product. Do not use VEREGEN® Ointment, 15% for warts in the vagina, cervix, or inside the anus. Avoid contact with your eyes, nostrils and mouth while ointment is on your finger(s).

Avoid use of VEREGEN® on open wounds. Do not expose skin that has been treated with VEREGEN® to the sunlight, sunlamps or tanning beds. Tell your doctor if you are using any other type of skin product on the area to be treated. Avoid sexual contact (genital, anal or oral) when VEREGEN® Ointment, 15% is on your genital or perianal skin. If you do choose to have sexual contact, you must wash off the ointment carefully before having protected sexual contact as the ointment may weaken condoms and vaginal diaphragms.

Be sure to tell the doctor if you have a weak immune system, if you are pregnant or nursing a baby, or if you have used VEREGEN® before. Avoid using this product in patients younger than 18 years of age or for longer than 16 weeks. If your warts do not go away or come back after treatment contact your doctor.

The most common side effects with VEREGEN® Ointment, 15% are local skin and application site reactions including: redness, itching, burning, pain, sores, swelling, hard spots, rash with blisters.

For more information, consult your healthcare professional.

You are encouraged to report negative side effects of prescription drugs to the Food and Drug Administration (FDA). Please visit www.FDA.gov/medwatch or call 1-800-FDA-1088.

If you have a product complaint about VEREGEN®, please call PharmaDerm customer service at 1-800-525-8747.

The information on this website should not take the place of talking with your healthcare professional. If you need medical information, please talk to your healthcare professional.

Please see link to full Patient Information. VEREGEN® (sinecatechins) Ointment, 15% Patient Information

Please see link to full Prescribing Information. VEREGEN® (sinecatechins) Ointment, 15% Full Prescribing Information

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ApexiCon® E Cream Indication

ApexiCon® E Cream is a topical prescription medication for the relief of the inflammatory (redness) and pruritic (itching) manifestations of corticosteroid-responsive skin conditions (such as atopic dermatitis or psoriasis).

Important Safety Information

Do not use ApexiCon® E Cream if you have a history of hypersensitivity to any of the ingredients of the preparation. If irritation develops, topical corticosteroids should be discontinued and appropriate therapy instituted. This medication is for external use only. Avoid contact with the eyes. The treated skin area should not be bandaged or otherwise covered or wrapped unless directed by the physician. Do not use tight-fitting diapers or plastic pants on an infant or child being treated in the diaper area, as this may increase the likelihood of the side effects.

Systemic absorption of topical corticosteroids through the skin has produced various hormonal abnormalities, increased blood sugar, and sugar in the urine in some patients. The following local side effects have been reported most commonly with topical corticosteroids: burning, itching, irritation, dryness.

The safety and effectiveness of this product in pediatric patients have not been established. Pediatric patients are more likely to develop toxicity affecting various organs. Side effects of topical steroids in children may include problems with growth, weight gain, headaches, problems with vision, bulging soft spots on a baby's head, and stretch marks.

If you are pregnant or nursing a baby, consult with physician prior to using this product.

For more information, consult your healthcare professional. Please see link to Full Prescribing Information below.

ApexiCon® E Cream (diflorasone diacetate cream USP 0.05% [emollient]) Full Prescribing Information

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.FDA.gov/medwatch or call 1-800-FDA-1088.

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