Active Ingredient
L-Menthol 5%
Medicated Pain Relief
FDA Label NDC 67510-1301
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 (NDC 67510-1301). 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
- simple backache
- bursitis
- muscle sprains
- bruises
Warnings
For external use only
When Using This Product
- use only as directed
- do not bandage tightly or use a heating pad
- avoid contact with eyes and mucous membrane
- do not apply to wounds or damaged skin
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 over 12 years:
- Carefully remove backing film from patch
- Apply one patch to affected area
- Repeat as necessary, but no more than 4 times daily.
Children 12 years or younger:
ask a doctor
Other Information
store at room temperature
Inactive Ingredients
dihydroxyaluminum aminoacetate, glycerol, kaolin, methylparaben, polyacrylic acid, propylene glycol, propylparaben, pvp, sodium polyacrylate, tartaric acid, titanium dioxide, tween 80, water
Package Label
Pain Relief Medicated Patch
* Please review the disclaimer below.
