Active Ingredient
Menthol 5%
Cold And Hot Medicated Pain Relief Large
FDA Label NDC 63941-948
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Valu Merchandisers Company, Inc. for the product Cold And Hot Medicated Pain Relief Large (NDC 63941-948). 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 ingredient, purpose, uses, warnings, when using this product, stop use and ask a doctor if, if pregnant or breast-feeding,, keep out of reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Topical analgesic
Uses
Temporarily relieves minor pain associated with:
- arthritis
- muscle strains
- simple backache
- bursitis
- cramps
- tendonitis
- muscle sprains
- bruises
Warnings
For external use only
When Using This Product
- use only as directed
- do not bandage tightly or use with heating pad
- avoid contact with eyes and mucous membranes
- do not apply to wounds or damaged skin
- do not use if you are allergic to any ingredients of this product
Stop Use And Ask A Doctor If
- condition worsens
- symptoms persist for more than 7 days or clear up and occur again within a few days
- redness is present
- irritation develops
If Pregnant Or Breast-Feeding,
ask a health professional before use.
Keep Out Of Reach Of Children.
If swallowed, get medical help or contact a Poison Control Center immediately.
Directions
Adults and children over 12 years:
- carefully remove backing from patch
- apply one patch to affected area
- repeat as necessary, but no more than 4 times daily
Children under 12 years of age: Ask a doctor
Inactive Ingredients
carboxymethylcellulose, dihydroxyaluminum aminoacetate, glycerin, kaolin, methylparaben, mineral oil, petrolatum, polyacrylic acid, polysorbate 80, propylene glycol, povidone, propylparaben, sodium polyacrylate, tartaric acid, titanium dioxide, water
Questions Or Comments?
call 1-800-883-0085
Reseal pouch after opening
Package Label
Best Choice Cold and Hot Large Medicated Patch
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