Otc - Active Ingredient
Active ingredient Purpose
Menthol 5%..................................................Topical analgesic
The following Structured Product Label (SPL) was submitted to the FDA by Topco Associates Llc for the product Topcare Cold And Hot Medicated (NDC 36800-860). 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, warnings, otc - do not use, otc - ask doctor, otc - when using, otc - stop use, otc - pregnancy or breast feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Active ingredient Purpose
Menthol 5%..................................................Topical analgesic
Uses
Warnings
For external use only
Do not use
Ask a doctor before use if you have
redness over the affected area
When using this product
Stop use and ask a doctor if
If pregnant or breast-feeding, ask a health professional before use.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away
Directions
Other information
Inactive ingredients
alcohol, aluminum glycinate, glycerin, kaolin, methylparaben, polysorbate 80, propylparaben, purified water, sodium polyacrylate, sorbitan monooleate, tartaric acid, titanium dioxide
Distributed by:
Topco Associates LLC
Elk Grove Village, IL 60007
Made in China
* Please review the disclaimer below.