Bonicaeasex Pain Relieving Lidocaine Patch
FDA Label NDC 75568-044
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Planet (anhui) Pharmaceutical Co., Ltd. for the product Bonicaeasex Pain Relieving Lidocaine (NDC 75568-044). 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 drug facts, active ingredient, purpose, use, warnings, do not use, when using this product, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient
Lidocaine 4%
Purpose
Topical Analgesic
Use
For temporary relief of pain
Warnings
For external use only
Do Not Use
• More than one patch on your body at a time • On cut, irritated or swollen skin • On puncture wounds • For more than one week without consulting a doctor • If you are allergic to any active or inactive ingredients • If pouch is damaged or opened
When Using This Product
• Use only as directed • Read and follow all directions and warnings • Do not allow contact with the eyes • Do not use at the same time as other topical anestetics • Do not bandage tightly or apply local heat (such as heating pads) to the area of use • Do not microwave • Dispose of used patch in minner that always keeps product away from children and pets. Used patches still contain the drug product that can produce serious adverse effects if a child or pet chews or ingests this patch.
Stop Use And Ask A Doctor If
• Conditions worsen • Redness is present • Irritation develops • Symptoms persist for more than 7 days clear up and occur again within a few days • You experience signs of skin injury, such as pain, swelling, or blistering where the product was applied
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 12 years of age and over:
• Clean and dry affected area • Carefully remove backing from patch • Apply stickly side of patch to affected area • Use one patch for up to 24 hours • Discard patch after single use • Apply 1 patch at a time to affected area, not more than 3 to 4 times daily
Children under 12 years of age:consult a physician.
Other Information
- Store in a clean, dry place outside of direct sunlight.
- Protect from excessive moisture
Inactive Ingredients
Aluminum Silicate, Mineral oil, Polyisobutylene, Propylene Glycol, Styrene-Isoprene-Styrene Block Copolymer, Terpene Resin.
Questions And Comments?
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