PAIN RELIVEING PATCH- lidocaine 4% patch

Pain Reliveing Patch by

Drug Labeling and Warnings

Pain Reliveing Patch by is a Otc medication manufactured, distributed, or labeled by Anhui Miao De Tang Pharmaceutical Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

LIDOCAINE PATCH 4%

ACTIVE INGREDIENT

Lidocaine 4% Topical anesthetic

PURPOSE

For the temporary relief of pain

INDICATIONS & USAGE

LIDOCAINE PATCH to help Temporarily relteves minor pain

WARNINGS

For external use only

Do not use more than 1 patch on vour bodv at a time on cut, irritated.or swolen skin on puncture wounds
for more than one week without consulting a doctor

DO NOT USE

use onlv as directed. Read and follow all directions and warnings on this carton. do not allow contact with the eyes
do not bandage tightly or apply local heat (such as heating pads) to the area of use do not use at the same time as other topical analcesics
dispose of used patch in manner 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.

WHEN USING

use onlv as directed. Read and follow all directions and warnings on this carton. do not allow contact with the eyes
do not bandage tightly or apply local heat (such as heating pads) to the area of use do not use at the same time as other topical analcesics
dispose of used patch in manner 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.
lf pregnant or breast-feeding, ask a health professional before use.

STOP USE

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

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away(1-800-222-1222).

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°-30°C (59°-86°F)

INACTIVE INGREDIENT

aluminum glycinate, glycerin, methyl acrylate, polyacrylic acid, polysorbate 80, propylene glycol.
sodium polvacrylate, tartaric acid, poval, alcohol, water

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

PAIN RELIVEING PATCH 
lidocaine 4% patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 81484-601
Route of Administration	TOPICAL

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

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 81484-601-02	5 in 1 BOX	06/01/2023
1	NDC: 81484-601-01	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	06/01/2023

Labeler - Anhui Miao De Tang Pharmaceutical Co., Ltd. (405744102)

Establishment
Name	Address	ID/FEI	Business Operations
Anhui Miao De Tang Pharmaceutical Co., Ltd.		405744102	manufacture(81484-601)