Active Ingredient
Lidocaine 4%
Pain Relief Patch
FDA Label NDC 69452-409
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Bionpharma Inc. for the product Pain Relief Patch (NDC 69452-409). 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 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
Purpose
Topical anesthetic
Uses
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
■ More than one patch on your body at a time or with other topical analgesics at the same time
■ For more than one week without consulting a doctor ■ With a heating pad ■ If pouch is damaged or opened.
When Using This Product
■ Avoid 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 contain the drug product that can produce serious adverse effect if a child or pet chews or ingests 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 such as rash, pain, itching, redness, irritation, swelling or blistering occur where the product was
applied.
If Pregnant Or Breast-Feeding,
ask a health professional before use.
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 ■ Discard patch after single use.
■ Children under 12 years of age: Consult a doctor.
Other Information
Store in a clean, dry place away from direct sunlight. Store in original unopened pouch protected from moisture.
Inactive Ingredients
alicyclic hydrocarbon resin, mineral oil, polyester film, silicone-coated polyester film, styrene isoprene, styrene block copolymer.
Questions Or Comments?
call toll free 1-888-235-2466 (Mon - Fri 9AM - 5PM EST)
Other
Read directions and warning before use
KEEP OUT OF REACH OF CHILDREN AND PETS
Made in USA from Domestic and Imported Components
Distributed by:
Bionpharma Inc.
Princeton, NJ
08540
L0000735
R0623
Carton Label
NDC 69452-409-04
maximum strength
a+ health TM
pain relief
lidocaine 4% patch
topical analgesic
• desensitizes aggravated nerves
• odor free, thin & flexible
• no-mess, single use application
24 hours
6 Patches
2.91" x 2.17"
Carton (Carton)
* Please review the disclaimer below.
