Active Ingredient
Lidocaine 4% w/w ...... Purpose: Topical anesthetic
Menthol 1% w/w ...... Purpose: Topical analgesic
Pain Relief Gel-patch
FDA Label NDC 73557-172
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Shanghai Chuangshi Medical Technology (group) Co., Ltd. for the product Pain Relief Gel-patch (NDC 73557-172). 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, purposes, uses, warnings, when using this product:, do not use:, stop use and ask a doctor if:, if pregnant or breast-feeding,, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purposes
Topical anesthetic (Lidocaine)
Topical analgesic (Menthol)
Uses
For temporary relief of pain
Warnings
For external use only
When Using This Product:
- Use only as directed
- Avoid contact with the eyes, mucous membranes or rashes
- Do not bandage tightly
Do Not Use:
- More than 1 patch at a time
- On wounds or damaged skin
- For more than one week without consulting a doctor
- If you are allergic to any ingredients of this product
Stop Use And Ask A Doctor If:
- Localized skin reactions occur, such as rash, itching, redness, irritation, pain, swelling and blistering
- Condition worsen
- Symptoms persist for more than 7 days
- Symptoms clear up and occur again within a few days
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
Adult and Children 12 years of age and over:
- Clean and dry affected area
- Remove film from patch and apply to the skin (see illustration)
- Apply 1 patch at a time to affected area, not more than 3 to 4 times daily
- Remove patch from the skin after at most 8-hour application
Children under 12 years of age: Consult a doctor
Inactive Ingredients
Water, Glycerin, Polyacrylic Acid, Propylene Glycol, Sodium Polyacrylate, Polysorbate 80, Mineral oil, Polyvinylpyrrolidone K90, Hydroxyacetophenone, L(+)-Tartaric Acid, Dihydroxyaluminium Aminoacetate, Edetate Disodium, Kaolin, Titanium Dioxide
Questions Or Comments
86-21-31166566
Other Information
- Store at 68-77℉ (20-25℃)
- Store in a cool dry place away from direct sunlight
Package Label. Principal Display Panel
01 (73557 172 01)
05 (73557 172 05)
* Please review the disclaimer below.
