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| Product NDC Code | 65923-122 | ||||
|---|---|---|---|---|---|
| Drug Name | Coralite extra strength pain relief sleeve wrist |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | PATCH | ||||
| Application Number | part348 | ||||
| Labeler Name | United Exchange Corp. | ||||
| 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 Purpose Menthol 16.0%.......................................Topical Analgesic Patch
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.Distributed by: United Exchange Corp. Cypress, CA 90630 USA Made in China
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients carbomber 940, ethanol, ethylparaben, glycerol, propylene glycol, purified water, trolamine
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.Directions Adults and children 12 years of age and older: open pouch and remove sleeve remove plastic insert and discard pull sleeve onto wrist, ankle or elbow until the colored (medicated) section of the sleeve is positioned directly over the affected area. Sleeve should feel snug, but not tight. Note: the drawings should help you understand how to do this. apply one sleeve to affected area no more than 3 times daily do not wear sleeve for more than 8 hours children under 12 years of age: consult a doctor
Purpose
Information about the drug product’s indications for use.Uses temporarily relieves minor aches and pains of muscles and joints associated with simple backache arthritis strains bruises sprains
Spl product data elements
Usually a list of ingredients in a drug product.Coralite Extra Strength Pain Relief Sleeve Wrist Menthol CARBOMER 940 ALCOHOL ETHYLPARABEN GLYCERIN PROPYLENE GLYCOL WATER TROLAMINE 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.90122
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 redness over the affected area
Do not use
Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.Do not use on wounds or damaged skin on a child under 12 years of age with arthritis-like conditions
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 immediately.
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 and ask a doctor if condition worsens, or if symptoms persist for more than 7 days symptoms clear up and occur again within a few days redness is present or irritation or rash develops
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 use only as directed avoid contact with the eyes, mucous membranes or rashes do not bandage tightly over sleeve or use with a heating pad discontinue use at least 1 hour before a bath or shower do not use immediately after a bath or shower
Pregnancy or breast feeding
Pregnancy or Breast feedingIf pregnant or breast-feeding, ask a health professional before use
Storage and handling
Information about safe storage and handling of the drug product.Other information store at room temperature 20-25°C (68-77°F)
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
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