PAIN RELIEVING PATCH- lidocaine 4% patch

Pain Relieving Patch by

Drug Labeling and Warnings

Pain Relieving Patch by is a Otc medication manufactured, distributed, or labeled by Hunan En Pu Pharmaceutical Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

LIDOCAINE PATCH

ACTIVE INGREDIENT

Lidocaine 4%

PURPOSE

Topical anesthetic

INDICATIONS & USAGE

For the temporary relief of pain

WARNINGS

For external use only

DO NOT USE

more than 1 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

WHEN USING

use only as directed. Read and follow all directions and warnings on this carton.
do not allow contact with the eyes
heat (such as heating pads) to the area of use
do not use at the same time as other topical analgesics
dispose of used patch in manner that always keeps product away from children and pets.
Used patches stll contain the drug product that can produce serious adverse effects if a child or pet chews or ingests this patch.

STOP USE

condition worsens
symptoms persist for more than 7 days or clear up and occur again within a few days
redness or irritation develops
you experience signs of skin injury, such as pain, sweling, or blistering where
the product was applied

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. lf swallowed, get medical help or contact a Poison Control Center right away

DOSAGE & ADMINISTRATION

Adults and children 12 years of age and older:
Wash and dry the affected area.
Peel off the backing film from one side of the patch carefully
Apply the exposed portion of the patch to the affected area.
Gently press the patch with your hand to fit the affected area completely.
Do not exercise vigorously during use to prevent the patch from falling off.
Use only 1 patch for a maximum of 8 hours.
Children under 12 years of age: Ask a doctor before use

STORAGE AND HANDLING

store at room temperature 15°-30C (59-86F).

INACTIVE INGREDIENT

aluminum glycinate
glycerin
methyl acrylate
polyacrylic acid
polysorbate 80
propylene glycol
sodium polyacrylate
tartaric acid
poval
alcohol

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

PAIN RELIEVING PATCH 
lidocaine 4% patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84273-001
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

Inactive Ingredients
Ingredient Name	Strength
TARTARIC ACID (UNII: W4888I119H)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
POLYVINYL ALCOHOL (18000 MW) (UNII: BRY146A46V)
ALCOHOL (UNII: 3K9958V90M)
POLYACRYLIC ACID (250000 MW) (UNII: 9G2MAD7J6W)
SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)
GLYCERIN (UNII: PDC6A3C0OX)
METHYL ACRYLATE (UNII: WC487PR91H)
DIHYDROXYALUMINUM AMINOACETATE ANHYDROUS (UNII: 1K713C615K)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84273-001-01	5 in 1 BOX	04/22/2024
1		1 in 1 BAG; 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	04/22/2024

Labeler - Hunan En Pu Pharmaceutical Co., Ltd. (842391330)

Establishment
Name	Address	ID/FEI	Business Operations
Hunan En Pu Pharmaceutical Co., Ltd.		842391330	manufacture(84273-001)