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| Product NDC Code | 67510-0300 | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Drug Name | Cold and hot pain relief |
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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 | Kareway Product, 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 5%
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 over 12 years: Remove backing from patch by grasping both ends firmly and gently pulling until backing separates in middle Carefully remove backing from patch Apply one patch to affected area Repeat as necessary, but no more than 4 times daily Children under 12 years of age: Ask a doctor
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients aluminium glycinate, carboxymethylcellulose, glycerin, kaolin, methylparaben, mineral oil, petrolatum, polyacrylic acid, povidone, propylene glycol, propylparaben, sodium polyacrylate, tartaric acid, titanium dioxide, tween 80, 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 pain associated with: arthritis muscle strains simple backache bursitis cramps tendonitis muscle sprains bruises
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.Cold and Hot Pain Relief Menthol GLYCERIN POLYSORBATE 80 SODIUM POLYACRYLATE (8000 MW) METHYLPARABEN PROPYLPARABEN WATER TARTARIC ACID TITANIUM DIOXIDE DIHYDROXYALUMINUM AMINOACETATE KAOLIN MENTHOL MENTHOL POLYACRYLIC ACID (250000 MW) POVIDONE POLYETHYLENE GLYCOL 400 CARBOXYMETHYLCELLULOSE MINERAL OIL PETROLATUM
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.package label Cold and Hot Pain Relief Patch carton
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 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 irritation 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 do not bandage tightly do not use a heating pad avoid contact with eyes and mucous membrane do not apply to wounds or damaged skin do not use if you are allergic to any ingredients of this product
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
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 When using this product use only as directed do not bandage tightly do not use a heating pad avoid contact with eyes and mucous membrane do not apply to wounds or damaged skin do not use if you are allergic to any ingredients of this 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 irritation develops If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center 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