HOT COLD LIDOCAINE WITH MENTHOL- lidocaine, menthol 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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HOT COLD LIDOCAINE WITH MENTHOL PATCH

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Lidocaine 4%

Menthol 1%

Purpose

Topical Anesthetic/ Analgesic

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

hot and cold china patch bulk

HOT COLD LIDOCAINE WITH MENTHOL 
lidocaine, menthol patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69159-004
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE40 mg
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL10 mg
Inactive Ingredients
Ingredient NameStrength
DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)  
DIHYDROXYALUMINUM AMINOACETATE (UNII: DO250MG0W6)  
GLYCERIN (UNII: PDC6A3C0OX)  
KAOLIN (UNII: 24H4NWX5CO)  
POLYACRYLIC ACID (300000 MW) (UNII: A8371R0U5J)  
POVIDONE (UNII: FZ989GH94E)  
SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)  
TARTARIC ACID (UNII: W4888I119H)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
WATER (UNII: 059QF0KO0R)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69159-004-01300 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: 5b1ffe32-1642-35e3-e053-2991aa0a7d8b
Set id: 58ebb3fe-08ff-e8b0-e053-2991aa0a56de
Version: 4
Effective Time: 20171009
 
Foshan Aqua Gel Biotech Co., Ltd.,