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| Product NDC Code | 65923-123 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | Coralite medicated heat |
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| Type | Brand | ||||||
| Active Ingredients |
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| Route | TOPICAL | ||||||
| Dosage Form | PATCH | ||||||
| RxCUI drug identifier | 1043399 | ||||||
| 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 Capsicum Extract Capsaicin 0.025%..............................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. 5836 Corporate Ave. Cypress, CA 90630 USA Made in China
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients lanolin, methyl salicylate, natural rubber, peppermint oil, petrolatum, rosin, zinc oxide
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: clean and dry affected area remove patch from film apply to affected area no more than 3 to 4 times daily do not wear patch more than 8 hours children under 12 years of age: consult a doctor
Purpose
Information about the drug product’s indications for use.Uses For temporary relief of minor aches and pains of muscles & joints associated with: Simple Backache Arthritis Strains Bruises Sprains
Spl product data elements
Usually a list of ingredients in a drug product.Coralite Medicated Heat Capsaicin LANOLIN METHYL SALICYLATE NATURAL LATEX RUBBER PEPPERMINT OIL PEPPERMINT PETROLATUM ROSIN ZINC OXIDE CAPSAICIN CAPSAICIN
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.90132A
90198
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.
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.
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, symptoms persist for more than 7 days or clear up and occur again within a few days redness is present or irritation or rash develops a severe burning sensation 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: do not use otherwise than directed avoid contact with the eyes, mucous membranes or rashes 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 breastfeeding, ask a health professional before use.
Storage and handling
Information about safe storage and handling of the drug product.Other information Avoid storing product in direct sunlight. Protect product from excessive moisture.
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 Allergy alert: do not use if you are allergic to capsicum, chili peppers, or any ingredients in this product if prone to allergic reaction from aspirin or salicylates, consult a doctor before use
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