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| Product NDC Code | 51452-037 | ||||
|---|---|---|---|---|---|
| Drug Name | Point relief cold spot pain relieving roll-on |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | LIQUID | ||||
| RxCUI drug identifier | 2121681, 2121685 |
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| Application Number | M017 | ||||
| Labeler Name | Fabrication Enterprises | ||||
| 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: menthol - USP 14% Purpose: external 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.Directions: Apply directly to affected area. Do not use more than four fimes per day.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Other Ingredients: aqua (deionized water), arnica montana flower (arnica) extract, boswellia serrata extract, carbomer, chondroitin sulfate, eucalyptus globulus oil, glucosamine sulfate, glycrrhiza glabra (licorice) extract, ilex paraguariensis leaf (yerba mate) extract, mentha piperita (peppermint) oil, methylisothiazolinone, MSM (dimethyl sulfone), polysorbate-20, SD-alcohol 40B, triethanolamine
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: For temporary relief of minor aches and pains of the muscles and joints associated with simple backache, arthritis, bruises, strains, and/ or sprains.
Purpose
Information about the drug product’s indications for use.Purpose: external analgesic
Spl product data elements
Usually a list of ingredients in a drug product.Point Relief cold Spot Pain Relieving roll-on MENTHOL WATER ARNICA MONTANA FLOWER INDIAN FRANKINCENSE CARBOXYPOLYMETHYLENE EUCALYPTUS OIL GLUCOSAMINE SULFATE GLYCYRRHIZA GLABRA ILEX PARAGUARIENSIS LEAF PEPPERMINT OIL METHYLISOTHIAZOLINONE DIMETHYL SULFONE POLYSORBATE 20 TROLAMINE MENTHOL MENTHOL
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: Label7
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
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 apply to open wounds or damaged skin If symptoms persist for more than sevan days, discontinue use and consult physician
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, consult physician Do not bandage tightly
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 Avoid contact with eyes Do not apply to open wounds or damaged skin If symptoms persist for more than sevan days, discontinue use and consult physician Keep out of reach of children If swallowed, consult physician Do not bandage tightly
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