LIDOCAINE PATCH- lidocaine 4%, menthol 1% patch

Lidocaine Patch by

Drug Labeling and Warnings

Lidocaine 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

ACTIVE INGREDIENT

Lidocaine 4%,Menthol 1%

PURPOSE

For the temporary relief of palin

INDICATIONS & USAGE

For the temporary relief of palin, TOPICAL ANESTHETIC

WARNINGS

For external use only

DO NOT USE

more than 1 patch on your body at a time or on cut, irritated or swollen skin

WHEN USING

use only as directod. Read and follow all directions and warnings on this label.
rare cases of serious bums have been reported with products of this type
do not apply to wounds or damaged, broken or irritated skin
do not allow contact with the eyes and mucous membranes
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 analgesics

STOP USE

condition worsens
rodness is present
irritation develops
symptoms persist for more than 7 days or clear up and occur again within a few days
you experience sians ot skin injury, such as pain, swelling, or blistering where the product was applied

KEEP OUT OF REACH OF CHILDREN

it swallowed, get medical help or contact Poison Control Center right away.

DOSAGE & ADMINISTRATION

Adults and children 12 years of age and over:
clean and dry aftecied area
remove backing from patch by firmly grasping both ends and gently pulling until backing separates in middle
carefully remave smaller portion of backing from patch and apply exposed portion of patch to atlected area
once exposed portion of patch is positioned, carefully remove remaining backing to completely applypatch to aitected area
use 2 patch tor up to 24 hours
Children under 12 years of age:consult a doctor

STORAGE AND HANDLING

Store in a clean, dry place outside of direct sunlight. Protect product from excessive moisture.

INACTIVE INGREDIENT

Aluminum Glycinate
Aluminum Hydroxide
Cellulose Gum
Glycerin
Methylparaben
PEG-40 Hydrogenated Castor Oil
Polyacrylic Acid
Polysorbate 80
Propylene Glycol
Ricinus Communis Seed Oil (Castor)
Silica
Sodium Polyacrylate
Tartaric Acid
Titanium Dioxide
Urea
Water

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

LIDOCAINE PATCH 
lidocaine 4%, menthol 1% patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 81484-901
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	0.01 g
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	0.04 g

Inactive Ingredients
Ingredient Name	Strength
POLYACRYLIC ACID (250000 MW) (UNII: 9G2MAD7J6W)
SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)
UREA (UNII: 8W8T17847W)
TARTARIC ACID (UNII: W4888I119H)
WATER (UNII: 059QF0KO0R)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
DIHYDROXYALUMINUM AMINOACETATE ANHYDROUS (UNII: 1K713C615K)
CARBOXYMETHYLCELLULOSE (UNII: 05JZI7B19X)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
METHYLPARABEN (UNII: A2I8C7HI9T)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
CASTOR OIL (UNII: D5340Y2I9G)
GLYCERIN (UNII: PDC6A3C0OX)
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 81484-901-03	2 in 1 PACKAGE	09/14/2023
1	NDC: 81484-901-02	6 in 1 BOX
1	NDC: 81484-901-01	1 in 1 BAG; Type 0: Not a Combination Product
2	NDC: 81484-901-04	30 in 1 BOX	11/14/2023
2	NDC: 81484-901-01	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	09/14/2023

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(81484-901)