Active Ingredient
Lidocaine 4%
Pain Patch Perfecto 24 Hours Lidocaine 4 % Patch
FDA Label NDC 83184-221
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Painpatchperfecto Llc for the product Pain Patch Perfecto 24 Hours Lidocaine 4 % Patch (NDC 83184-221). 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, use, warnings, do not use, when using this product, stop use and ask a doctor if, otc - pregnancy or breast feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Topical anesthetic
Use
For the temporary relief of minor pain.
Warnings
For External Use Only
Do Not Use
• If you are allergic to any active or inactive ingredients of this product
• On wounds or damaged, irritated or sensitive skin
• With any other topical anesthetic
• For more than one week without consulting a doctor
• With a heating pad
• If pouch is damaged or opened.
When Using This Product
• Do not allow contact with the eyes
• Use only as directed
• Read and follow all directions and warnings on this package
• Do not bandage tightly or apply local heat to the area of use
• Do not reuse patch
• Keep this product away from pets and children. Used patches still contains the drug product that can produce serious adverse effect if child or pet chews or ingest this patch.
Stop Use And Ask A Doctor If
• Condition worsens
• Symptoms persist for more than seven days or clear up and occur again within a few days
• Localized skin reactions occur such as rash, pain, itching, redness, irritation, swelling or blistering where the product was applied.
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children and pets. If chewed or swallowed, get medical help or contact a Poison Control Center right away (800-222-1222).
Directions
Adults and children 12 years of age and over: Clean and dry affected area. Apply immediately upon removal from pouch. Peel off the first liner and apply exposed patch to affected area. Peel off second liner while applying the rest of patch. Remove patch after 24 hours. Do not expose area to heat.
Children under 12 years of age: Consult a doctor.
Inactive Ingredients
Alicyclic hydrocarbon resin, mineral oil, polyester film, silicon-coated polyester film and styrene isoprene styrene block copolymer.
Other Information
Store in a clean, dry place away from direct sunlight. Store in original unopened pouch. protected from moisture.
Questions ?
Customer Care Help Line 866-295-5889 Monday - Friday 8:30 a.m. - 4:30 p.m. PST
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