Active Ingredient
Lidocaine 4%
Pain Relieving Gel-patch
FDA Label NDC 73557-159
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 Relieving Gel-patch (NDC 73557-159). 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, do not use, when using this product, stop use ... if, ... ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Topical Anesthetic
Uses
For temporary relief of pain
Warnings
For external use only
Do Not Use
- More than 1 patch at a time
- On wounds or damaged skin
- With a heating pad
- If you are allergic to any ingredients of this product
When Using This Product
- Use only as directed
- Avoid contact with the eyes, mucous membranes or rashes
- Do not bandage tightly
Stop Use ... If
- localized skin reactions occur, such as rash, itching, redness, irritation, pain, swelling and blistering
- Conditions worsen
- Symptoms persists for more than 7 days
- Symptoms clear up and occur again within a few days
... Ask A Doctor If
- localized skin reactions occur, such as rash, itching, redness, irritation, pain, swelling and blistering
- Conditions worsen
- Symptoms persists 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
Dosage Forms & Strengths
This is a strip, patch dosage form.
The active ingredient strength is 4% w/w.
One patch one time, no more than 8 hours one time.
Other Information
- Avoid storing product in direct sunlight
- Protect product from excessive moisture
Inactive Ingredients
Dihydroxyaluminum Aminoacetate, Edetate Disodium, Glycerin,Hydroxyacetophenone， Kaolin, Polysorbate80，Propylene Glycol, Polyacrylic Acid, PVP, Sodium Polyacrylate, Tartaric Acid, Titanium Dioxide, Water
Questions Or Comments
86-21-31166566 [email protected]
Package Label. Principal Display Panel
Box (159 06 Box)
Patch (159 06 Patch)
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