Other
Drug Facts
The following Structured Product Label (SPL) was submitted to the FDA by Veridian Healthcare for the product Healthwise Soothing Cold Therapy Gel (NDC 71101-050). 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 other, active ingredients, purpose, uses, warnings, ask a doctor before use if you have, when using this product, do not, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Drug Facts
Menthol 4%
Topical analgesic
Uses Temporary relief from minor aches and pains of sore muscles and joints associated with:
■arthritis ■backache ■strains■sprains
For external use only
Flammable: keep away from excessive heat or open flame
When using this product:
■ avoid contact with eyes or mucous membranes
■ do not apply to wounds or damaged skin
■ do not use with other ointments, creams, sprays
or liniments
■do not apply to irritated skin or if excessive irritation develops
■do not bandage
■ wash hands after use with cool water
■do not use with a heating pad or device
Stop use and ask a doctor if: the condition worsens, if the symptoms last more than 7 days or clear up and reoccur
If pregnant or breast-feeding, ask a health professional before use.
Keep out of reach of children. In case of accidental ingestion, get medical help or contact a Poison Control Center (800-222-1222) right away.
Directions
Adults and children 2 years of age and older:■rub a thin film over affected area not more than 4 times daily, massage not necessary Children under 2 years of age: consult physician
Inactive ingredients aloe barbadensis leaf juice, aminomethyl propanol,arctium lappa extract, arnica montana flower extract, Boswellia serrata extract, calendula officinalis flower extract, camellia sinensis leaf extract, camphor, carbomer, FD&Cyellow
no.5, FD&C blue no.1, glycerin, ilex paraguariensis leaf extract, isopropyl alcohol,isopropyl myristate, melissa officinalis leaf extract, methyl methacrylate crosspolymer, tocopheryl acetate, water
* Please review the disclaimer below.