Active Ingredient
Menthol 5%
The following Structured Product Label (SPL) was submitted to the FDA by Veridian Healthcare, Llc for the product Healthwise Medicated Cold Hot (NDC 71101-991). 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 active ingredient, purpose, uses, warnings, when using this product, stop use and consult a doctor if, if pregnant or breast-feeding, keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Menthol 5%
External analgesic
For temporary relief of minor aches and pains of muscles and joints: arthritis, simple backache, bursitis, tendonitis, muscle strains, muscle sprains, bruises and cramps.
For external use only
When using this product:
Stop use and consult a doctor if:
If pregnant or breast-feeding, ask a health professional before use.
Keep out of reach of children. Do not use on infants. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
Adults and children 12 years of age and over: Clean and dry affected area, free of lotions, ointments and creams. Carefully remove backing from patch. Apply sticky side of patch to affected area. Do not use more than one patch in an 8 hour period. Repeat as necessary. Maximum 3 patches per day. Discard patch after single use. Reseal pouch after opening.
Children under 12 years of age: consult a physician.
Store at room temperature, not to exceed 86°F (30°C).
alcohol, aluminum glycinate, benzyl alcohol, carboxymethylcellulose sodium, edetate disodium, ethylhexylglycerin, glycerin, isopropyl myristate, kaolin, methacrylate copolymer, phenoxyethanol, polysorbate 80, povidone, sodium polyacrylate, sorbitan monooleate, sorbitol, tartaric acid, titanium dioxide, water
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