WELMATE LIDOCAINE PAIN RELIEVING PATCH- lidocaine patch 
Yyba Corporation

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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Welmate Lidocaine Pain Relieving Patch

Active ingredient

Lidocaine 4%

Purpose

Topical anesthetic

Uses

For temporary relieves minor pain

Warnings

For external use only

Do not use

  • more than one patch on your body at a time
  • On cut, irritated or swollen skin
  • On puncture wounds
  • For more than one week without consulting a doctor
  • If you are allergic to any active or inactive ingredients
  • if pouch is damaged or opened.

When using this product

  • use only as directed
  • read and follow directions and warnings on this carton
  • do not allow contact with eyes.
  • Do not use at the same time as other topical analgesics
  • Do not bandage tightly or apply local heat (such as heating pads) to the area of use
  • Do not microwave
  • Dispose of used patch in manner that always keeps product 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

  • conditions worsen
  • Redness is present
  • irritation develops
  • symptoms persist for more than 7 days or clear up and occur 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 and pets

If swallowed, get medical help or contact a Poison Control Center 800-222-1222 right away.

Directions

Adults and children 12 years of age and over:

Children under 12 years of age: consult a physician

Other information

Inactive ingredients

aluminum glycinate, carboxymethylcellulose sodium, glycerin, iodopropynyl butylcarbamate, kaolin, petrolatum, phenoxyethanol, polyacrylic acid, polysorbate80, povidone, propylene glycol, sodium polyacrylate, tartaric acid, titanium dioxide, water, 3-(2-ethylhexyloxy)propane-1,2-diol

Questions or comments?

Toll free 866-933-6337 www.salonpas.us

Principal Display Panel

labellabelPack

WELMATE LIDOCAINE PAIN RELIEVING PATCH 
lidocaine patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73581-911
Route of AdministrationTOPICAL, PERCUTANEOUS, TRANSDERMAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE4 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
POLYACRYLIC ACID (8000 MW) (UNII: 73861X4K5F)  
PETROLATUM (UNII: 4T6H12BN9U)  
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
DIHYDROXYALUMINUM AMINOACETATE (UNII: DO250MG0W6)  
SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)  
KAOLIN (UNII: 24H4NWX5CO)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
TARTARIC ACID (UNII: W4888I119H)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:73581-911-3030 in 1 CARTON11/01/2021
111 g in 1 POUCH; Type 0: Not a Combination Product
2NDC:73581-911-1515 in 1 CARTON09/01/2022
211 g in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34811/01/2021
Labeler - Yyba Corporation (006339772)
Establishment
NameAddressID/FEIBusiness Operations
Foshan Aqua Gel Biotech Co., Ltd.,529128763manufacture(73581-911)

Revised: 9/2022
Document Id: e8bc96bc-7878-4906-e053-2a95a90ae6ba
Set id: cff71b75-fc4e-29ac-e053-2995a90abd50
Version: 2
Effective Time: 20220915
 
Yyba Corporation