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Product NDC Code | 63936-0975 | ||||
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Drug Name | Stopain clinical |
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Type | Brand | ||||
Active Ingredients |
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Route | TOPICAL | ||||
Dosage Form | GEL | ||||
RxCUI drug identifier | 259249, 1865942 |
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Application Number | M017 | ||||
Labeler Name | Troy Manufacturing, Inc. | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredient Menthol 10.0%
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: ask a doctor. Children 12 years or younger: apply directly onto affected area without the need to bandage repeat if necessary, but do not apply more than 4 times daily.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients acrylic acid/vinyl ester copolymer, dimethylsulfone (MSM), eucalyptus oil, glucosamine sulfate, hydroxypropylcellulose, SD alcohol 39C, PEG-8 dimethicone, pentylene glycol, peppermint oil, triethanolamine, water (USP)
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 the temporary relief of minor aches and pains of muscles and joints associated with: simple backache arthritis strains bruises sprains
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.Stopain Clinical MENTHOL, UNSPECIFIED FORM DIMETHYL SULFONE EUCALYPTUS OIL GLUCOSAMINE SULFATE HYDROXYPROPYL CELLULOSE, UNSPECIFIED PEG-8 DIMETHICONE PENTYLENE GLYCOL PEPPERMINT OIL TROLAMINE WATER MENTHOL, UNSPECIFIED FORM 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 Label 5g
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.
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 Avoid contact with eyes. 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