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| Product NDC Code | 72342-120 | ||||
|---|---|---|---|---|---|
| Drug Name | Pain relief roll on extra strength, cooling |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | GEL | ||||
| RxCUI drug identifier | 415976 | ||||
| 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 6%
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 12 years of age and older: Apply to affected area not more 4 times a day Massage painful area until absorbed into skin Wash hands after each use with cold water Children under 12 years of age: consult a doctor.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Aloe barbadensis leaf extract, Arnica montana flower extract, carbomer homopolymer type C (allyl pentaerythritol crosslinked), denatured alcohol, ethylhexylglycerin, glycerin, Melaleuca alternafolia (tea tree) leaf oil, organic Ilex paraguariensis (yerba mate) leaf, phenoxyethanol, propylene glycol, triethanolamine, tocopheryl acetate (vitamin E), 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 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.Pain Relief Roll On Extra Strength, Cooling MENTHOL, UNSPECIFIED FORM ALOE VERA LEAF ARNICA MONTANA FLOWER CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) ALCOHOL ETHYLHEXYLGLYCERIN GLYCERIN TEA TREE OIL ILEX PARAGUARIENSIS LEAF PHENOXYETHANOL PROPYLENE GLYCOL TROLAMINE .ALPHA.-TOCOPHEROL ACETATE WATER 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 - 79 g Bottle Label EXTRA STRENGTH* ESTD 1868 J.R. WATKINS REMEDIES FOR BODY™ COOLING PAIN RELIEF ROLL-ON USED BY ATHLETES WITH NATURAL MENTHOL, ARNICA & VITAMIN E FAST-ACTING MENTHOL PAIN RELIEF FOR BACKACHES, SORE MUSCLES, & JOINT PAIN Net wt. 2.8 oz (79 g) PRINCIPAL DISPLAY PANEL - 79 g Bottle 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 open wounds, damaged or irritated skin With a heading pad or TENS device With any other creams, ointments, sprays, liniments, or other topical products containing menthol
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? J.R WATKINS, LLC OAKLAND, CA 94612 1-888-384-1945 JRWATKINS.COM
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 Rash, itching, redness, or excessive irritation of skin develops Symptoms persist for more than 7 days Symptoms clear up and occur again within a few days
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 Do not bandage tightly Use only as directed Avoid contact with eyes or mucous membranes
Pregnancy or breast feeding
Pregnancy or Breast feedingIf pregnant or breastfeeding Ask a health professional before use.
Storage and handling
Information about safe storage and handling of the drug product.Other information 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 and heated surfaces. Do not use On open wounds, damaged or irritated skin With a heading pad or TENS device With any other creams, ointments, sprays, liniments, or other topical products containing menthol When using this product Do not bandage tightly Use only as directed Avoid contact with eyes or mucous membranes Stop use and ask a doctor if Condition worsens Rash, itching, redness, or excessive irritation of skin develops Symptoms persist for more than 7 days Symptoms clear up and occur again within a few days If pregnant or breastfeeding 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