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Coralite cold and hot medicated - Medication Information

Product NDC Code 65923-154
Drug Name

Coralite cold and hot medicated

Type Brand
Active Ingredients
Menthol 5 mg/g
Route TOPICAL
Dosage Form PATCH
RxCUI drug identifier 420222
Application Number part348
Labeler Name United Exchange Corporation
Packages
Package NDC Code Description
65923-154-01 1 patch in 1 pouch (65923-154-01) / 5 g in 1 patch
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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 feeding
If 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