Keralyt label

Keralyt

Keralyt Recall

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Side Effects & Adverse Reactions

WARNINGS: Prolonged use over large areas, especially in children and those patients with significant renal or hepatic impairment, could result in salicylism. Concomitant use of other drugs which may contribute to elevated serum salicylate levels should be avoided where the potential for toxicity is present. In children under 12 years of age and those patients with renal or hepatic impairment, the area to be treated should be limited and the patient monitored closely for signs of salicylate toxicity: nausea, vomiting, dizziness, loss of hearing, tinnitus, lethargy, hyperpnoea, diarrhea, psychic disturbances. In the event of salicylic acid toxicity, the use of KERALYT GEL should be discontinued. Fluids should be administered to promote urinary excretion. Treatment with sodium bicarbonate (oral or intravenous) should be instituted as appropriate. Considering the potential risk of developing Reye’s Syndrome, salicylate products should not be administered to children or teenagers with varicella or influenza, unless directed by a physician.

WARNINGS: Prolonged use over large areas, especially in children and those patients with significant renal or hepatic impairment, could result in salicylism. Concomitant use of other drugs which may contribute to elevated serum salicylate levels should be avoided where the potential for toxicity is present. In children under 12 years of age and those patients with renal or hepatic impairment, the area to be treated should be limited and the patient monitored closely for signs of salicylate toxicity: nausea, vomiting, dizziness, loss of hearing, tinnitus, lethargy, hyperpnoea, diarrhea, psychic disturbances. In the event of salicylic acid toxicity, the use of KERALYT SHAMPOO should be discontinued. Fluids should be administered to promote urinary excretion. Treatment with sodium bicarbonate (oral or intravenous) should be instituted as appropriate. Considering the potential risk of developing Reye’s Syndrome, salicylate products should not be administered to children or teenagers with varicella or influenza, unless directed by a physician.

FDA Safety Alerts

There are currently no FDA safety alerts available for this drug.

Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.

Uses

INDICATIONS AND USAGE – For the removal of excess keratin in hyperkeratotic disorders, including scaling associated with scalp psoriasis or thickened skin of palms and soles, corns and calluses.

INDICATIONS AND USAGE – For the removal of excess keratin in hyperkeratotic disorders, including scaling associated with scalp psoriasis or thickened skin of palms and soles, corns and calluses.

History

There is currently no drug history available for this drug.

Other Information

DESCRIPTION: KERALYT® is a gel for topical administration containing salicylic acid 6%, in a vehicle composed of propylene glycol, SD-40 alcohol (21%), hydroxypropylcellulose and purified water. Salicylic acid is the 2 hydroxy derivative of benzoic acid having the following structure:

Salicylic Acid Chemical Structure

DESCRIPTION: KERALYT® shampoo contains 6% w/w salicylic acid USP in a vehicle composed of purified water, ammonium lauryl sulfosuccinate, cocamidopropyl betaine, hexylene glycol, linoleamidopropyl PG-dimonium chloride phosphate, polyquaternium-22, propylene glycol, sodium C14-16 olefin sulfonate, sodium citrate, sodium lauroyl sarcosinate, tetrasodium EDTA, tocopherol acetate and fragrance. Salicylic acid is the 2 hydroxy derivative of benzoic acid having the following structure:

Salicylic Acid Chemical Structure

Keralyt Manufacturers

  • Keralyt | Summers Laboratories Inc
    No Recall

    Keralyt | Summers Laboratories Inc

    Keralyt | Summers Laboratories Inc

    DOSAGE AND ADMINISTRATION - The preferable method of use is to apply KERALYT GEL thoroughly to the affected area and occlude the area at night. Preferably, the skin should be hydrated for at least five minutes prior to application. The medication is washed off in the morning and if excessive drying and/or irritation is observed a bland cream or lotion may be applied. Once clearing is apparent, the occasional use of KERALYT GEL will usually maintain the remission. In those areas where occlusion is difficult or impossible, application may be made more frequently; hydration by wet packs or baths prior to application apparently enhances the effect. Unless hands are being treated, hands should be rinsed thoroughly after application. For use as a scalp treatment: KERALYT GEL should be applied directly to the affected areas of the scalp on a frequency directed by your physician. The applicator tip will provide accurate application, avoiding contact with normal hair or skin. The gel should be washed off after 10 to 20 minutes initially, but it can be left on for up to an hour as treatment progresses. The gel can be washed off using KERALYT SHAMPOO or warm water in a bath or shower.

    DOSAGE AND ADMINISTRATION - For use as a concentrated scalp treatment BEFORE bathing: Do not wet hair. Twist open applicator tip and apply KERALYT SHAMPOO w/applicator evenly, directly to affected areas of the scalp. Leave on for 5 minutes, gradually increasing treatment time up to one hour, or as directed by physician. Wash hands after applying KERALYT SHAMPOO w/applicator. After treatment, rinse thoroughly with water. Although no additional shampoo is needed to cleanse hair, a non-medicated shampoo may be used if desired. For use as a medicated shampoo: Wet hair and apply KERALYT SHAMPOO w/applicator to the scalp. Work into a lather, leave on for several minutes, then rinse. Use daily until the condition clears. After clearing is apparent, use KERALYT SHAMPOO w/applicator occasionally to maintain clearing or as directed by your physician.

  • Keralyt | Summers Laboratories Inc
    No Recall

    Keralyt | Summers Laboratories Inc

    Keralyt | Summers Laboratories Inc

    DOSAGE AND ADMINISTRATION
    For use as a concentrated scalp treatment BEFORE bathing: Do not wet hair. Twist open applicator tip and apply KERALYT SHAMPOO w/applicator evenly, directly to affected areas of the scalp. Leave on for 5 minutes, gradually increasing treatment time up to one hour, or as directed by physician. Wash hands after applying KERALYT SHAMPOO w/applicator. After treatment, rinse thoroughly with water. Although no additional shampoo is needed to cleanse hair, a non-medicated shampoo may be used if desired. For use as a medicated shampoo: Wet hair and apply KERALYT SHAMPOO w/applicator to the scalp. Work into a lather, leave on for several minutes, then rinse. Use daily until the condition clears. After clearing is apparent, use KERALYT SHAMPOO w/applicator occasionally to maintain clearing or as directed by your physician.

  • Keralyt | Chemco Corporation
    No Recall

    Keralyt | Chemco Corporation

    Keralyt | Chemco Corporation

    Caution: Discontinue use if excessive irritation of the skin develops. Avoid getting into eyes or mucous membranes. If condition worsens, or symptoms persist for more than 7 days or clear up and occur again within a few days, or redness is present, or in conditions affecting children under 12 years of age, discontinue use and consult a physician immediately.

  • Keralyt | Summers Laboratories Inc
    No Recall

    Keralyt | Summers Laboratories Inc

    Keralyt | Summers Laboratories Inc

    DOSAGE AND ADMINISTRATION - The preferable method of use is to apply KERALYT GEL thoroughly to the affected area and occlude the area at night. Preferably, the skin should be hydrated for at least five minutes prior to application. The medication is washed off in the morning and if excessive drying and/or irritation is observed a bland cream or lotion may be applied. Once clearing is apparent, the occasional use of KERALYT GEL will usually maintain the remission. In those areas where occlusion is difficult or impossible, application may be made more frequently; hydration by wet packs or baths prior to application apparently enhances the effect. Unless hands are being treated, hands should be rinsed thoroughly after application. For use as a scalp treatment: KERALYT GEL should be applied directly to the affected areas of the scalp on a frequency directed by your physician. The applicator tip will provide accurate application, avoiding contact with normal hair or skin. The gel should be washed off after 10 to 20 minutes initially, but it can be left on for up to an hour as treatment progresses. The gel can be washed off using KERALYT SHAMPOO or warm water in a bath or shower.