LIDOCAINE PATCH- lidocaine patch 
Foshan Aqua Gel Biotech Co., Ltd.,

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Maximum Strength Lidocaine Patch- bulk label

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Lidocaine 4%

Purpose

Topical Anesthetic

Uses

Temporarily relieves minor pain

Warnings

For external use only

Do Not Use

When Using This Product

Stop Use and Ask a Doctor if

If Pregnant or Breast Feeding

ask a health professional before use.

Keep Out of Reach of Children and Pets

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

Directions

Adults and children over 12 years:

children 12 years or younger: ask a doctor

Directions

Adults and children over 12 years:

children 12 years or younger: ask a doctor

Inactive Ingredients

Dihydroxyaluminum aminoacetate, Glycerol, Kaolin, Methylparaben, Polyacrylic acid, Propylene glycol, Propylparaben, PVP, Sodium polyacrylate, Tartaric acid, Titanium dioxide, Tween 80, Water

Outer Label

lidocaine china bulk patch

LIDOCAINE PATCH 
lidocaine patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69159-003
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE40 mg
Inactive Ingredients
Ingredient NameStrength
SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)  
KAOLIN (UNII: 24H4NWX5CO)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
POVIDONE (UNII: FZ989GH94E)  
DIHYDROXYALUMINUM AMINOACETATE (UNII: DO250MG0W6)  
GLYCEROL (1-(12-HYDROXYSTEARATE)) (UNII: X84XWP4TOC)  
POLYACRYLIC ACID (250000 MW) (UNII: 9G2MAD7J6W)  
TARTARIC ACID (UNII: W4888I119H)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
WATER (UNII: 059QF0KO0R)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69159-003-01300 in 1 CASE09/11/2017
11 in 1 PATCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34809/11/2017
Labeler - Foshan Aqua Gel Biotech Co., Ltd., (529128763)

Revised: 10/2017
Document Id: 5b1fb8e5-c303-9a32-e053-2a91aa0a7f5a
Set id: 58eb2d50-6790-50f1-e053-2a91aa0aec36
Version: 4
Effective Time: 20171009
 
Foshan Aqua Gel Biotech Co., Ltd.,