LIDOCAINE PATCH- lidocaine hci 4% 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 HCI 4% Purpose:Topical Analgesic

PURPOSE

For the temporary relief of pain，LIDOCAINE PATCH

INDICATIONS & USAGE

LIDOCAINE PATCH to help Temporarily relteves minor pain

WARNINGS

For external use only. Flammable.

DO NOT USE

More than 1 patch at a time
On wounds or damaged skin
With a heating pad
If you have ever had an allergic reaction to this product or any of its ingredients

WHEN USING

Use only as directed
Avoid contact with the eyes, mucous membranes or rashes

Do not bandage tightly

STOP USE

Localized skin reaction occur, such as rash, itching, redness, iritation, pain, swelling and blistering

Condition worsens
Symptoms persist for more than 7 days

Symptoms clear up and occur again within a few days

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.

DOSAGE & ADMINISTRATION

Adults and children over 12 years:
·Wash and dry the affected areaRemove backing from patch by firmty grasping both ends and gently pulling until backing separates in the middle
· Carefully remove smaller portion of back,ng from patch and apply exposed portion of patch to aected areaOnce exposed portion of

· patch is pooned.carefully remove remaining backing tocomplelely apply patch to afected areaCarefully remove smaller portion of

· backing from patch and apply exposed portion of patch to affected area

· Use only 1 patch for a maximum of 24 hours

STORAGE AND HANDLING

· Keep away from direc sunlight or heat
· Store at room temperature (68-77F/20-25°C)
· Protect product from excessive moisture
· Patch comes in individual packaging

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, Menthol

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

LIDOCAINE PATCH 
lidocaine hci 4% patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 81484-501
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	0.4 g

Inactive Ingredients
Ingredient Name	Strength
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
GLYCERIN (UNII: PDC6A3C0OX)
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)
DIHYDROXYALUMINUM AMINOACETATE ANHYDROUS (UNII: 1K713C615K)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
METHYLPARABEN (UNII: A2I8C7HI9T)
TARTARIC ACID (UNII: W4888I119H)
CARBOXYMETHYLCELLULOSE SODIUM (0.9 CARBOXYMETHYL SUBSTITUTION PER SACCHARIDE; 130 MPA.S AT 4%) (UNII: 0891BL4S3D)
POLYACRYLIC ACID (250000 MW) (UNII: 9G2MAD7J6W)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
CASTOR OIL (UNII: D5340Y2I9G)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
UREA (UNII: 8W8T17847W)
WATER (UNII: 059QF0KO0R)
SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
RACEMENTHOL (UNII: YS08XHA860)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 81484-501-02	30 in 1 BOX	03/14/2023
1	NDC: 81484-501-01	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	03/14/2023

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(81484-501)