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| Product NDC Code | 37205-824 | ||||
|---|---|---|---|---|---|
| Drug Name | Pain relieving |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | GEL | ||||
| RxCUI drug identifier | 808955 | ||||
| Application Number | part348 | ||||
| Labeler Name | Cardinal Health | ||||
| 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 Ingredients Active Ingredients Menthol 3.5% Purpose Cooling Pain Relief
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 / Children 2 years and older: Massage onto affected area up to 4 times daily. • Children under 2 years of age: Consult physician
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients: Water, isopropyl alcohol, herbal extract (IIex paraguariensis), menthol, carbomer, triethanolamine, silicon dioxide, methylparaben, glycerine, propylene glycol, FDandC blue #1
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 Temporary relief from minor aches and pains of sore muscles and joints associated with • arthritis • backache • strains • sprains
Purpose
Information about the drug product’s indications for use.Purpose Cooling Pain Relief
Spl product data elements
Usually a list of ingredients in a drug product.Pain Relieving MENTHOL WATER ISOPROPYL ALCOHOL TROLAMINE SILICON DIOXIDE METHYLPARABEN GLYCERIN PROPYLENE GLYCOL FD&C BLUE NO. 1 MENTHOL, UNSPECIFIED FORM MENTHOL, UNSPECIFIED FORM
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: PainRelievingGelA
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: Store in cool dry place, lid closed tightly. keep away from excessive heat or open flame.
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: sensitive skin, are pregnant or breast feeding
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 ingested, get medical help. Contact Poison Control Center immediately.
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 more than 7 days, or clear up and recur
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: • Avoid contact with eyes or mucous membranes • Do not apply to wounds, damaged or irritated skin, or if excessive irritation develops • Do not bandage or use with heating pad or device. ointments, creams, sprays. liniments • Wash hands after with cool water
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 Ask a doctor before use if you have: sensitive skin, are pregnant or breast feeding When Using This Product: • Avoid contact with eyes or mucous membranes • Do not apply to wounds, damaged or irritated skin, or if excessive irritation develops • Do not bandage or use with heating pad or device. ointments, creams, sprays. liniments • Wash hands after with cool water Stop Use And Ask A Doctor If: Condition worsens. symptoms persist more than 7 days, or clear up and recur Keep out of reach of children: If ingested, get medical help. Contact Poison Control Center immediately.
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