Otc - Active Ingredient
Camphor 3.1%, Menthol 6.0%, Methyl salicylate 10.0%
Pain Patch
FDA Label NDC 87255-005
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Shenzhen Mengyue Technology Co., Ltd. for the product Pain (NDC 87255-005). 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 otc - active ingredient, otc - purpose, indications & usage, warnings, otc - do not use, otc - when using, otc - stop use, otc - 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
Otc - Purpose
Topical analgesic
Indications & Usage
Uses
For temporary relief of minor aches & pains of muscles & joints associated with:
- Arthritis
- Simple backache
- Strains
- Bruises
- Sprains
Warnings
Warnings
For external use only
Allergy alert: If prone to allergic reaction from aspirin or salicylates, consult a doctor before use.
Otc - Do Not Use
Do not use
- On wounds or damaged skin
- With a heating pad
- If you are allergic to any ingredients of this product
Otc - When Using
When using this product
- Use only as directed
- Avoid contact with the eyes, mucous membranes or rashes
- Do not bandage tightly
Otc - Stop Use
Stop use and ask a doctor if
- Skin reactions such as redness, itching, rash, excessive irritation, burning sensation, swelling or blistering occur
- Conditions worsen
- Symptoms persist for more than 7 days
- Symptoms clear up and occur again within a few days
If pregnant or breastfeeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
If swallowed, get medical help or contact a Poison Control Center right away.
Dosage & Administration
Directions
- Adults and children 12 years of age and over:
- clean and dry affected area remove patch from film
- apply to affected area not more than 3 to 4 times daiy
- remove patch from the skin after at most 8-hour application
Children under 12 years of age:
consult a doctor
Storage And Handling
Other information
Store in a clean, dry place outside of direct sunlight. Protect product form excessive moisture.
Inactive Ingredient
Inactive ingredients
Acrylamide, glycerin, purified water
Package Label.Principal Display Panel
87255-005-01 (87255 005 01)
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