Assured Calamine
Assured Calamine is an FDA drug label for the active ingredient CALAMINE 8% AND ZINC OXIDE 8% manufactured by Greenbriar International 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 20231218.
Generic: CALAMINE 8% AND ZINC OXIDE 8%
Manufacturer: Greenbriar International
Product Type: HUMAN OTC DRUG
Route: TOPICAL
Dosage Form:
NDC: 33992-4130
Application: M016
Effective: 20231218
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 6 months of age: Consult a doctor before use.
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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