Warnings
For external use only
Flammable: Keep away from excessive heat or open flame
Quality Choice Cold Therapy Gel
FDA Label NDC 83324-007
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Chain Drug Marketing Association, Inc. for the product Quality Choice Cold Therapy Gel (NDC 83324-007). 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 warnings, ask a doctor before use if you have:, when using this product:, stop use an ask a doctor if, if pregnant or breastfeeding:, keep out of reach of children., directions, other info, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Ask A Doctor Before Use If You Have:
sensitive skin
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 An Ask A Doctor If
condition worsens, if symptoms last more than 7 days or clear up and reoccur
If Pregnant Or Breastfeeding:
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
adults and children 2 years of age and older:
- rub a thin film over affected area not more than 4 times daily, massage is not necessary
children under 2 years of age: consult a physician
Other Info
■ store in a cool dry place
■ do not use if tube seal under cap is broken
Inactive Ingredients
Inactive ingredients
benzyl alcohol, butylated hydroxytoluene, camphor, carbopol 940, edetate disodium, DMDM hydantoin, FD&C blue no. 1, FD&C yellow no. 5,isopropyl alcohol, PEG-40 hydrogenated castor oil, sodium hydroxide, water
Uses
Temporarily relieves minor aches and pains of muscles and joints associated with:
- arthritis
- backache
- strains
- sprains
Active Ingredient
Menthol 4%
Purpose
Topical analgesic
Package Label.Principal Display Panel
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