Otc - Active Ingredient
Calamine 8%
Pramoxine Hydochloride 1%
Topcare Calagesic Lotion
FDA Label NDC 36800-268
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 Calagesic (NDC 36800-268). 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
External analgesic
Indications & Usage
Dries the oozing and weeping, and temporarily relieves pain and itching of poison ivy, oak, and sumac or other skin irritations.
Warnings
For external use only. Use only as directed.
When using this product. Avoid contact with eyes and moucous membranes.
Otc - Keep Out Of Reach Of Children
In case of accidental ingestion, seek profesional assistance or contact a Poison Control Center immediately.
Dosage & Administration
Adults and children 2 yr. of age and older. Shake well before using. Cleanse the skin with soap and water and let dry. Apply to the affected area using cotton or soft cloth, not more than 3 to 4 times daily as needed for comfort.
Children under 2 yrs. of age. Consult a doctor before use.
Inactive Ingredient
SD Alcohol 38B 2.5%, Camphor, Diazolidinyl Urea, Fragrances, Glycerin, Hydroxypropyl Methycelulose, Methylparaben, Polysorbate 80, Propylene Glycol, Propylparaben and Purified Water.
* Please review the disclaimer below.
