Calamine

Calamine is an FDA drug label for the active ingredient CALAMINE 8% AND ZINC OXIDE 8% manufactured by Pharma Nobis, LLC administered by TOPICAL. This page reproduces the FDA-approved indications and usage, dosage, contraindications, warnings, and adverse reactions exactly as published in the drug label. Data source: openFDA (U.S. FDA), label effective 20231222.

Generic: CALAMINE 8% AND ZINC OXIDE 8%

Manufacturer: Pharma Nobis, LLC

Product Type: HUMAN OTC DRUG

Route: TOPICAL

Dosage Form:

NDC: 82645-900

Application: M016

Effective: 20231222

Active Ingredients: Active Ingredients Calamine 8% and Zinc Oxide 8%

Indications & Usage

Uses dries the oozing and weeping o poison ivy, poison oak, and poison sumac.

Dosage & Administration

Directions Adults and chidren 2 years of age and older: shake well before using. Cleanse the skin with soap and water and let it dry befroe each use. Apply lotion to the affected area using a cotton or soft cloth, as often as needed for comfort. Children under 2 years of age: Consult a doctor before use Directions Children under 2 years of age: Consult a doctor before use (12/2021)

Contraindications

Not available.

Warnings

Warnings For external use only. Use only as directed. Avoid contact with eyes and mucous membranes. Ask a doctor before using on chilren 6 months of age.

Adverse Reactions

Not available.

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