Label: WELMATE LIDOCAINE PAIN RELIEVING PATCH- lidocaine patch
- NDC Code(s): 73581-911-15, 73581-911-30
- Packager: Yyba Corporation
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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 Label Information
Updated September 15, 2022
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- Official Label (Printer Friendly)
- Active ingredient
- Purpose
- Uses
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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.
- Directions
- Other information
- Inactive ingredients
- Questions or comments?
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INGREDIENTS AND APPEARANCE
WELMATE LIDOCAINE PAIN RELIEVING PATCH
lidocaine patchProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:73581-911 Route of Administration TOPICAL, PERCUTANEOUS, TRANSDERMAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE 4 g in 100 g Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:73581-911-30 30 in 1 CARTON 11/01/2021 1 11 g in 1 POUCH; Type 0: Not a Combination Product 2 NDC:73581-911-15 15 in 1 CARTON 09/01/2022 2 11 g in 1 POUCH; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 11/01/2021 Labeler - Yyba Corporation (006339772) Establishment Name Address ID/FEI Business Operations Foshan Aqua Gel Biotech Co., Ltd., 529128763 manufacture(73581-911)