Active Ingredients
Menthol 5% . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Topical Analgesic
Rugby Menthol Hot Cold Patch
FDA Label NDC 0536-1332
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Rugby Laboratories for the product Rugby Menthol Hot Cold Patch (NDC 0536-1332). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredients, purpose, warnings, when using this product, stop use and consult a doctor, otc - pregnancy or breast feeding, keep out of reach of children, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Topical analgesic
Warnings
For external use only
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
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.
Otc - Pregnancy Or Breast Feeding
If pregnant or breastfeeding, ask a health professional before use.
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.
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.
Other Safety Information
Store at room temperature, not to exceed 86F (30C)
Inactive Ingredients
CMC, dihydroxyaluminum aminoacetate, Glycerin, Kaolin, Methylparaben, Petrolatum, Polyacrylic Acid, Polysorbate 80, Propylene Glycol, Propylparaben, PVP, Sodium Polyacrylate, Tartaric Acid, Titanium Dioxide, Water
Questions
Call 1-800-645-2158
Indications & Usage
Targeted, long-lasting pain relief
* Please review the disclaimer below.
