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Pain relief extra strength, cooling - Medication Information

Product NDC Code 72342-130
Drug Name

Pain relief extra strength, cooling

Type Brand
Active Ingredients
Menthol, unspecified form 6 g/100ml
Route TOPICAL
Dosage Form AEROSOL, SPRAY
RxCUI drug identifier 259550
Application Number M017
Labeler Name J.R. Watkins, LLC.
Packages
Package NDC Code Description
72342-130-18 118 ml in 1 bottle, spray (72342-130-18)
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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, denatured alcohol, glycerin, Melaleuca alternafolia (tea tree) leaf oil, organic Ilex paraguariensis (yerba mate) leaf, 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 Extra Strength, Cooling MENTHOL, UNSPECIFIED FORM ALOE VERA LEAF ARNICA MONTANA FLOWER ALCOHOL GLYCERIN TEA TREE OIL ILEX PARAGUARIENSIS LEAF .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 - 118 mL Bottle Label EXTRA STRENGTH* ESTD 1868 J.R. WATKINS REMEDIES FOR BODY™ COOLING PAIN RELIEF SPRAY WITH NATURAL MENTHOL, ARNICA & VITAMIN E FAST-ACTING MENTHOL PAIN RELIEF FOR BACKACHES, SORE MUSCLES, & JOINT PAIN 4.0 fl oz (118 mL) USED BY ATHLETES PRINCIPAL DISPLAY PANEL - 118 mL 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 you have sensitive skin 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 Contents under pressure Do not puncture or incinerate Do not store at temperature above 120 deg. F

Pregnancy or breast feeding

Pregnancy or Breast feeding
If 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 Contents under pressure Do not puncture or incinerate Do not store at temperature above 120 deg. F Stop use and ask a doctor if Condition worsens you have sensitive skin 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