FDA Label for Rugby Menthol Hot Cold Patch
View Indications, Usage & Precautions
Rugby Menthol Hot Cold Patch Product Label
The following document was submitted to the FDA by the labeler of this product Rugby Laboratories. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Active Ingredients
Menthol 5% . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Topical Analgesic
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
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