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| Product NDC Code | 72342-020 | ||||
|---|---|---|---|---|---|
| Drug Name | Pain relieving cooling |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | GEL | ||||
| RxCUI drug identifier | 259150 | ||||
| Application Number | M017 | ||||
| Labeler Name | J.R. Watkins, LLC. | ||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredient MENTHOL 3%
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 Use only as directed Adults and children 2 years and older: Apply liberally to painful area not more than 3-4 times daily. Children under 2 years of age: Ask a doctor. Wash hands carefully after using
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Acrylates/C10-30 alkyl acrylate crosspolymer, polysorbate 60, SD alcohol 40B, tromethamine, water
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 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.Pain Relieving Cooling MENTHOL, UNSPECIFIED FORM ALCOHOL WATER TROMETHAMINE POLYSORBATE 60 CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) 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.PRINCIPAL DISPLAY PANEL - 93 g Tube Label TRUSTED REMEDIES SINCE 1868 ESTD 1868 J.R. WATKINS REMEDIES FOR BODY ® PAIN RELIEVING COOLING GEL WITH NATURAL MENTHOL TEMPORARY RELIEF FOR MUSCLES & JOINTS NET WT. 3.3 OZ (93 g) PRINCIPAL DISPLAY PANEL - 93 g Tube 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
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 a heading pad
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.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions or Comments? 1-888-384-1945
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 for more than 7 days symptoms clear up and occur again within a few days rash or irritation occurs
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, nostrils and mouth do not bandage tightly
Storage and handling
Information about safe storage and handling of the drug product.Other information do not use if tamper evident seal is not intact store away from children store in dry, well-ventilated conditions at room temperature (59-77°F)
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. Flammable: Keep away from fire or flame. Do not use on wounds or damaged skin with a heading pad When using this product avoid contact with eyes, nostrils and mouth do not bandage tightly Stop use and ask a doctor if condition worsens symptoms persist for more than 7 days symptoms clear up and occur again within a few days rash or irritation occurs 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