PAIN RELIEF PATCH- lidocaine 4% patch

pain relief patch by

Drug Labeling and Warnings

pain relief patch by is a Otc medication manufactured, distributed, or labeled by Bionpharma Inc., Sparsha Pharma USA, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Lidocaine 4%

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)

SPL UNCLASSIFIED SECTION

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"

INGREDIENTS AND APPEARANCE

PAIN RELIEF PATCH 
lidocaine 4% patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69452-409
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	4 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
HYDROGENATED C6-20 POLYOLEFIN (100 CST) (UNII: 39EYQ1W9RB)
STYRENE/ISOPRENE/STYRENE BLOCK COPOLYMER (STYRENE/ISOPRENE 15/85) (UNII: 1SSZ6HXE7P)
MINERAL OIL (UNII: T5L8T28FGP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69452-409-04	6 in 1 CARTON	10/04/2024
1		1 g in 1 POUCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	10/04/2024

Labeler - Bionpharma Inc. (079637826)

Registrant - Bionpharma Inc. (079637826)

Establishment
Name	Address	ID/FEI	Business Operations
Sparsha Pharma USA, Inc.		079365856	manufacture(69452-409)