Otc - Active Ingredient
Calamine 8% and Zinc Oxide 8%
Topcare Calamine Lotion
FDA Label NDC 36800-702
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Topco Associates Llc for the product Topcare Calamine (NDC 36800-702). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, indications & usage, warnings, otc - keep out of reach of children, dosage & administration, inactive ingredient, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Skin protectant
Indications & Usage
dries the oozing and weeping o poison ivy, poison oak, and poison sumac.
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.
Otc - Keep Out Of Reach Of Children
In case of accidental ingestion, seek professional assistance or contact a Poison Control center immediately.
Dosage & Administration
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.
Inactive Ingredient
Bentonite magma, calcium hydroxide, glycerin, purified water.
Package Label.Principal Display Panel
Cl (Cl)
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