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| Product NDC Code | 69771-012 | ||||
|---|---|---|---|---|---|
| Drug Name | Gerigentle frostyheat pain relief patch back |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | PATCH | ||||
| Application Number | M017 | ||||
| Labeler Name | Geri-Gentle 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 Menthol 5% Purpose Topical anesthetic
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 12 years of age and over:Clean and dry affected area. Children under 12 years of age: consult a physician. clean and dry affected area remove film from patch and apply to skin apply 1 patch at a time to affected area, not more than 3 to 4 times daily. wear each patch up to 8 hours maximum.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients: Glycerin, Sodium polyacrylate, Dihydroxyaluminum Aminoacetate, Methylparaben, Propylparaben, Titanium Dioxide, Kaolin, Polysorbate 80, Propylene Glycol, Tartaric Acid, PVP, Polyacrylic Acid, Water, Petrolatum, CMC, Mineral Oil.
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.Use Temporarily relieves minor aches and pains of muscles and joints due to arthritis simple backache strains sprains bruises.
Purpose
Information about the drug product’s indications for use.Purpose Topical anesthetic
Spl product data elements
Usually a list of ingredients in a drug product.GeriGentle FrostyHeat Pain Relief Patch Back MENTHOL MENTHOL MENTHOL GLYCERIN DIHYDROXYALUMINUM AMINOACETATE METHYLPARABEN PROPYLPARABEN TITANIUM DIOXIDE KAOLIN POLYSORBATE 80 PROPYLENE GLYCOL TARTARIC ACID POVIDONE, UNSPECIFIED WATER PETROLATUM CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED MINERAL OIL
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 Labeling: Outer Package3 Inner Package3 Label03
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.Drug Facts
Other information: Avoid storing product in direct sunlight Protect product from excessive moisture
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 heating pad if you are allergic to any ingredient of this product.
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 and pets. 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 conditions worsen excessive redness or irritation is present symptoms persist for more than 7 days symptoms clear up and occur again within a few days.
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 and mucous membranes or rashes
Pregnancy or breast feeding
Pregnancy or Breast feedingIf pregnant or breast-feeding, ask a health care professional before use.
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 Do not use on wounds or damaged skin with heating pad if you are allergic to any ingredient of this product. When using this product use only as directed avoid contact with eyes and mucous membranes or rashes Stop use and ask a doctor if conditions worsen excessive redness or irritation is present symptoms persist for more than 7 days symptoms clear up and occur again within a few days. If pregnant or breast-feeding, ask a health care professional before use. Keep out of reach of children and pets. 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