LIDOCAINE PATCH- lidocaine 4% menthol 1% patch 
Anhui Miao De Tang Pharmaceutical Co., Ltd.

----------

Lidocaine Patch

LIDOCAINE PATCH

Active Ingredient(s)

LIDOCAINE 4% Purpose:Topical Analgesic

MENTHOL 1% Purpose: External Analges

Purpose

Topical Anesthetic, External Analges, LIDOCAINE PATCH

Use

LIDOCAINE PATCH to help Temporarily relteves minor pain

Warnings

For external use only. Flammable.

Do not use

• More than one patch on your body at a time or on cut, irritated or swollen skin
• On open or puncture wounds

• For more than one week without consulling a doctor.


• Use only as directed. Read and邸ow all directions and warnings on this label.
• Rare cases of serious burns have been reported with products of this type.
• Oo not apply to wou心s 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.
• Dispose of used patch in manner that always keeps producl 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.

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

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

Directions

Adults and children over 12 years:


• Wash and dry the affected area.
• Remove 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 a什ected area
• Once exposed portion of patch is po奾oned.carefully remove remaining backing tocomplelely apply patch to affected area.
• Carefully 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.

Other information

Inactive ingredients

aluminum glycinate, glycerin, sodium polyacrylate. tartaric acid, DMOM hydantoin, water

Package Label - Principal Display Panel

label

LIDOCAINE PATCH 
lidocaine 4% menthol 1% patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81484-301
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL0.1 g
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE0.4 g
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX)  
DMDM HYDANTOIN (UNII: BYR0546TOW)  
TARTARIC ACID (UNII: W4888I119H)  
SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)  
DIHYDROXYALUMINUM AMINOACETATE (UNII: DO250MG0W6)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:81484-301-026 in 1 BOX11/01/2021
1NDC:81484-301-011 in 1 BAG; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01711/01/2021
Labeler - Anhui Miao De Tang Pharmaceutical Co., Ltd. (405744102)
Establishment
NameAddressID/FEIBusiness Operations
Anhui Miao De Tang Pharmaceutical Co., Ltd.405744102manufacture(81484-301)

Revised: 11/2023
Document Id: 0a284cca-a827-7498-e063-6394a90a9aa7
Set id: cfba14e4-a834-a071-e053-2a95a90a658f
Version: 4
Effective Time: 20231114
 
Anhui Miao De Tang Pharmaceutical Co., Ltd.