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| Product NDC Code | 63936-8523 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | Extra strength stopain cold pain relieving roll on |
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| Type | Brand | ||||||
| Active Ingredients |
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| Route | TOPICAL | ||||||
| Dosage Form | LIQUID | ||||||
| RxCUI drug identifier | 727162 | ||||||
| Application Number | M017 | ||||||
| Labeler Name | TROY MANUFACTURING, 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 8.0% Purpose Topical 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 roll directly onto affected area without the need to rub, massage or bandage Adults and children over 12 years: • • repeat if necessary, but do not apply more than 4 times daily ask a doctor. Children 12 years or younger:
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients boswellia serrata extract, carbomer, dimethylsulfone (MSM), eucalyptus oil, glucosamine sulfate, glycerin, peppermint oil, SD alcohol 39C, 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.EXTRA STRENGTH STOPAIN COLD PAIN RELIEVING ROLL ON MENTHOL INDIAN FRANKINCENSE CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE DIMETHYL SULFONE EUCALYPTUS OIL GLUCOSAMINE SULFATE GLYCERIN PEPPERMINT OIL ALCOHOL TROLAMINE WATER 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: 63936-8700-1 Box2
Package Labeling: 63936-8700-2 Outer Label Inner Label
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
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, or if symptoms persist for more than 7 days or clear up and occur again within a few days. • redness is present • excessive irritation of the skin 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 or use a heating pad • do not apply to wounds or damaged skin
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 Avoid contact with eyes. For external use only. Flammable: Keep away from fire or flame. When using this product • use only as directed • do not bandage tightly or use a heating pad • do not apply to wounds or damaged skin Stop use and ask a doctor if • condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days. • redness is present • excessive irritation of the skin 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