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Assured Pain Relief by Foshan Aqua Gel Biotech Co., Ltd.,

Dosage form: gel
Ingredients: LIDOCAINE 4g in 100g
Labeler: Foshan Aqua Gel Biotech Co., Ltd.,
NDC Code: 69159-100

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.

Drug Facts

Active ingredients

Lidocaine 4%

Purpose

Topical analgesic

Uses  temporarily releives minor pain

Warnings  for external use only.

Do not use

•more than one patch on your body at a time or on cut  •on wounds or damaged skin  •with a heating pad

When using this product

•avoid contact with eyes, mucous membranes or rashes  •use only as directed  •do not bandage tightly

•do not use at the same time as other topical analgesics  •dispose of used patch in a manner that always keeps products away from children and pets

Stop  use and ask a doctor if

•you experience signs of skin injury, such as pain, swelling or blistering where product was applied •symptoms persist for more than 7

days or clear up and occur again within a few days  •condition worsens  •redness is present  •irritation develops

Keep out of reach of children. On case of accidental ingestion, get medical help or contact a Poison Control Center right away.

Pregnancy.breast-feeding warning. If pregant or breast-feeding, ask a health professional before use.

Directions  Adults and children 12 years of age and over:

•Clean and dry affected area  •Remove film from patch and apply to the skin (see package for instructions)

•Apply to affected area not more than 3 to 4 times daily  •Remove patch from the skin after at most 8 hours of application

Children under 12 years of age: consult a physician

Other information

•Store at room temperature 58° - 86° F (15° - 30° C). Acoid storing product in direct sunlight  •Protect product from excessive moisture

Inactive ingredients DIHYDROXYALUMINUM AMINOACETATE, GLYCERIN, KAOLIN, METHYLPARABEN, PROPYLPARABEN, PROPYLENE GLYCOL,

PVP, POLYACRYLIC ACID, POLYSORBATE 80, SODIUM POLYACRYLATE, TITANIUM DIOXIDE, TARTARIC ACID, WATER

ASSURED PAIN RELIEF 
lidocaine gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69159-100
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE (LIDOCAINE) LIDOCAINE4 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
DIHYDROXYALUMINUM AMINOACETATE 
GLYCERIN 
KAOLIN 
METHYLPARABEN 
PROPYLPARABEN 
PROPYLENE GLYCOL 
POVIDONE, UNSPECIFIED 
POLYACRYLIC ACID (8000 MW) 
POLYSORBATE 80 
SODIUM POLYACRYLATE (8000 MW) 
TITANIUM DIOXIDE 
TARTARIC ACID 
WATER 
Packaging
#Item CodePackage Description
1NDC:69159-100-0115 g in 1 PATCH
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34808/20/2017
Labeler - Foshan Aqua Gel Biotech Co., Ltd., (529128763)
Establishment
NameAddressID/FEIOperations
Foshan Aqua Gel Biotech Co., Ltd.,529128763manufacture(69159-100)

Revised: 09/2017
 
Foshan Aqua Gel Biotech Co., Ltd.,

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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