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| Product NDC Code | 65923-154 | ||||
|---|---|---|---|---|---|
| Drug Name | Coralite cold and hot medicated |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | PATCH | ||||
| RxCUI drug identifier | 420222 | ||||
| Application Number | part348 | ||||
| Labeler Name | United Exchange Corporation | ||||
| 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 5%..................................Topical Analgesic
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 1-800-814-8028 Made in China
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients alcohol, aluminum glycinate, glycerin, kaolin, methylparaben, polysorbate 80, propylparaben, purified water, sodium polyacrylate, sorbitan monooleate, tartaric acid, titanium dioxide
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 open pouch and removew patch carefully peel off protective backing and apply sticky side to affected area adults and children 12 years of age and older: do not wear patch for more than 8 hours apply to affected area no more than 3 times daily children under 12 years of age: consult a doctor
Purpose
Information about the drug product’s indications for use.Uses temporarily relives minor aches and pains of muscles and joints associated with: simple backache arthritis strains brusies sprains
Spl product data elements
Usually a list of ingredients in a drug product.Coralite Cold and Hot Medicated MENTHOL TARTARIC ACID DIHYDROXYALUMINUM AMINOACETATE ANHYDROUS SODIUM POLYACRYLATE (2500000 MW) METHYLPARABEN POLYSORBATE 80 WATER TITANIUM DIOXIDE MENTHOL MENTHOL ALCOHOL GLYCERIN KAOLIN PROPYLPARABEN SORBITAN MONOOLEATE
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.90151
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 with a heating pad 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 (1-800-222-1222) right away.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions or comments? Call 1-800-814-8028 Monday-Friday 9AM-5PM (PST)
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.Stope use and ask a doctor if condition worsens or symptoms persist for more than 7 days symptoms clear up and occur again within a few days excessive skin irritation occurs
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 eyes or mucous membranes do not bandage tightly 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