LIDOCAINE PAIN RELIEF PATCH- lidocaine and menthol, unspecified form 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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Lidocaine Pain Relief Patch

Active Ingredients

Lidocaine 4%

Menthol 1%

Purpose:

Topical anesthetic

Topical anesthetic

Uses:

For the temporary relief of pain.

Warnings

For external use only
Avoid contact with eyes.

Do not use

  • if you are allergic to any active and inactive ingredients listed in this patch
  • if pouch is damaged or opened
  • on raw surfaces or blistered areas, open wounds, or on damaged, cut, irriated or sensitive skin
  • for more than one week without consulting a doctor.

When using this product

  • use only as directed. Read and follow all directions and warnings on this package
  • do not allow contact with eyes or 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
  • do not reuse patch
  • dispose of used patch in manner that always keeps product away from children or 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

  • conditions worsens
  • rash, itching or skin irritation develops
  • symptoms persist for more than 7 days or clear up and occurs again within a few days
  • you experience signs of skin injury, such as pain, swelling, or blistering where the product was applied.

If pregnant or breast feeding

ask a health professional before use.

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 of age:

Children under 12 years: ask a doctor before use.

Other Information

Store below 25°C (77°F). Avoid direct sunilght.

Inactive Ingredients:

dihydroxyaluminum aminoacetate, glycerin,kaolin,methylparaben,polyacrylic acid,polysorbate 80,propylene glycol,propylparaben, povidone,sodium polyacrylate, tartaric acid,tatanium dioxide,water.

Questions or Comments?

Please call 1-800-290-6816 (Mon-Fri 9AM-5PM CST)

Dosage and Administration

Lidocaine Pain Relief Patch contains 4% Lidocaine and 1% Menthol.

Lidocaine Pain Relief Patch

package

LIDOCAINE PAIN RELIEF PATCH 
lidocaine and menthol, unspecified form patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69159-920
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM1 g  in 100 g
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE4 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
POLYACRYLIC ACID (250000 MW) (UNII: 9G2MAD7J6W)  
DIHYDROXYALUMINUM AMINOACETATE (UNII: DO250MG0W6)  
GLYCERIN (UNII: PDC6A3C0OX)  
KAOLIN (UNII: 24H4NWX5CO)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
WATER (UNII: 059QF0KO0R)  
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
TARTARIC ACID (UNII: W4888I119H)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
Color    Score    
ShapeRECTANGLESize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69159-920-051 in 1 CARTON09/01/2016
15 in 1 POUCH
19 g in 1 PATCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34809/01/2016
Labeler - Foshan Aqua Gel Biotech Co.,Ltd. (529128763)

Revised: 11/2017
Document Id: 5d539dfd-9d87-c162-e053-2991aa0a51c0
Set id: 3fe1a160-6508-62ea-e054-00144ff8d46c
Version: 2
Effective Time: 20171106
 
Foshan Aqua Gel Biotech Co.,Ltd.