Active Ingredients
L-Menthol 0.4%
Capsicum Extract (0.002% of Capsaicin)
Medicated Pain Relief Hot
FDA Label NDC 67510-0226
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Kareway Product, Inc. for the product Medicated Pain Relief Hot (NDC 67510-0226). 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, purposes, 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
Purposes
Topical analgesic
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
- do not use a heating pad
- avoid contact with eyes and mucous membrane
- 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 right away
Directions
Adults and children 12 years of age and older: Clean and dry affected area. Remove backing film and apply not more than 3 to 4 times daily.
Children under 12 years of age: Consult a physician.
Other Information
store at 20° to 25°C (68° to 77°F)
Inactive Ingredients
Purified water, Glycerin, Disodium edetate, Tartaric acid, Gelatine, Polyvinyl alcohol, Sodium polyacrylate, Vitamin E acetate, Aloe vera
* Please review the disclaimer below.
