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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device adhesive backed thermal skin patches
Regulation Description Hot or cold disposable pack.
Definition Pain relief heat patches for temporary relief of muscular and joint pian assoiciated with arthritis, simple backache, muscle strains and sprains.External use only. Not on damaged skin or open sores. Do no use under the age of 12. Do use on people who are not able to feel pain. Patch is applied directly to site of pain over intact skin for up to 8 hours but not more than once in a 24 hour period. Do not use more than 7 days. Over the counter device. No prescription. Do not sleep on or put pressure on heat patch for extended period of time. Do not use with any creams or oils. Can remove body hair upon patch removal due to adhesive. Can cause burns.
Product CodeOMW
Regulation Number 890.5710
Device Class 1

Device Problems
No Known Device Problem 2
No Information 1
Malfunction 1
Total Device Problems 4