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Rugby menthol hot cold patch - Medication Information

Product NDC Code 0536-1332
Drug Name

Rugby menthol hot cold patch

Type Brand
Active Ingredients
Menthol, unspecified form 5 g/100g
Route TOPICAL
Dosage Form PATCH
RxCUI drug identifier 420222
Application Number M017
Labeler Name RUGBY LABORATORIES
Packages
Package NDC Code Description
0536-1332-15 5 patch in 1 carton (0536-1332-15) / 9 g in 1 patch
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active Ingredients Menthol 5% . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 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 Directions Adults and children 12 years of age and over: carefully remove backing from patch apply sticky side of patch to affected area wear one patch up to 8 hours repeat as necessary, but no more than 3 times daily discard patch after single use reseal pouch after opening. Children under 12 years of age: consult a physician.

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Inactive Ingredients CMC, dihydroxyaluminum aminoacetate, Glycerin, Kaolin, Mineral Oil, Methylparaben, Petrolatum, Polyacrylic Acid, Polysorbate 80, Propylene Glycol, Propylparaben, PVP, Sodium Polyacrylate, Tartaric Acid, Titanium Dioxide, 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.
Targeted, long-lasting pain relief

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.
Rugby Menthol Hot Cold Patch Menthol DIHYDROXYALUMINUM AMINOACETATE MINERAL OIL GLYCERIN KAOLIN METHYLPARABEN POLYACRYLIC ACID (8000 MW) POLYSORBATE 80 PROPYLENE GLYCOL PETROLATUM POVIDONE, UNSPECIFIED PROPYLPARABEN TARTARIC ACID TITANIUM DIOXIDE WATER CARBOXYMETHYLCELLULOSE SODIUM POLYACRYLATE (8000 MW) 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.
Rugby Menthol Cold / Hot Patch label

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 Do not use on infants. If swallowed, get medical help or contact a Poison Control Center (800-222-1222) right away.

Other safety information

Information about safe use and handling of the product that may not have been specified in another field.
Other safety information Store at room temperature, not to exceed 86F (30C)

Questions

A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.
Questions Call 1-800-645-2158

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 consult a doctor ■ condition worsens ■ redness is present ■ irritation develops ■ symptoms persist for more than 7 days or clear up and occur again within a few days ■ you experience signs of skin injury, such as pain, swelling or blistering where the product was applied.

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 ■ Rare cases of serious burns have been reported with products of this type ■ don't bandage tightly or use with a heating pad ■ Avoid contact with the eyes and mucous membranes ■Don't apply to wounds or damaged skin ■ do not use at the same time as other topical analgesics

Pregnancy or breast feeding

Pregnancy or Breast feeding
If pregnant or breastfeeding, ask a health professional before use.

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

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