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| Product NDC Code | 83324-007 | ||||
|---|---|---|---|---|---|
| Drug Name | Quality choice cold therapy gel |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | GEL | ||||
| RxCUI drug identifier | 415974 | ||||
| Application Number | M017 | ||||
| Labeler Name | Chain Drug Marketing Association, Inc. | ||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient Menthol 4%
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.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
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.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
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.Uses Temporarily relieves minor aches and pains of muscles and joints associated with: arthritis backache strains sprains
Purpose
Information about the drug product’s indications for use.Purpose Topical analgesic
Spl product data elements
Usually a list of ingredients in a drug product.Quality Choice Cold Therapy Gel Menthol CAMPHOR (NATURAL) CARBOMER 940 BENZYL ALCOHOL ISOPROPYL ALCOHOL EDETATE DISODIUM POLYOXYL 40 HYDROGENATED CASTOR OIL BUTYLATED HYDROXYTOLUENE WATER DMDM HYDANTOIN SODIUM HYDROXIDE FD&C BLUE NO. 1 FD&C YELLOW NO. 5 MENTHOL MENTHOL
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.label
Ask doctor
Information about when a doctor should be consulted about existing conditions or sumptoms before using the drug product, including all warnings for persons with certain preexisting conditions (excluding pregnancy) and all warnings for persons experiencing certain symptoms. The warnings under this heading are those intended only for situations in which consumers should not use the product until a doctor is consulted.Ask a doctor before use if you have: sensitive skin
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Other Info ■ store in a cool dry place ■ do not use if tube seal under cap is broken
Stop use
Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.Stop use an ask a doctor if condition worsens, if symptoms last more than 7 days or clear up and reoccur
When using
Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.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
Pregnancy or breast feeding
Pregnancy or Breast feedingIf pregnant or breastfeeding: ask a health professional before use
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.Warnings For external use only Flammable: Keep away from excessive heat or open flame 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
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API