Active Ingredient
Menthol 5%
Soundbody Cold And Hot Pain Relief
FDA Label NDC 67510-0287
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 Soundbody Cold And Hot Pain Relief (NDC 67510-0287). 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
- 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 over 12 years:
- Remove backing from patch by grasping both ends firmly and gently pulling until backing separates in middle
- 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
Other Information
store at room temperature
Inactive Ingredients
aluminium glycinate, 1,3-butylene glycol, carboxymethylcellulose sodium, concentrated glycerin, diethylene glycol monoethyl ether, disodium edetate, methyl parahydroxybenzoate, polyacrylic acid solution, polysorbate 80, propyl parahydroxybenzoate, purified water, tartaric acid, titanium dioxide
Package Label
Cold and Hot Pain Relief Patch
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