Label: LOXYINE- lidocaine patch
- NDC Code(s): 83658-011-01
- Packager: Sj Incorporation Ltd
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
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Drug Label Information
Updated November 20, 2023
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- 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 all directions and warning on this pack
- Do not allow contact with the eyes
- Do not use at the same time as other topical analgesics
- Do not bandage only 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
LOXYINE
lidocaine patchProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:83658-011 Route of Administration TOPICAL, PERCUTANEOUS, TRANSDERMAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE 4 mg in 100 mg Inactive Ingredients Ingredient Name Strength ALUMINIUM TRIGLYCINATE (UNII: 5TLG1CL557) GLYCERIN (UNII: PDC6A3C0OX) KAOLIN (UNII: 24H4NWX5CO) METHYLPARABEN (UNII: A2I8C7HI9T) POLYACRYLIC ACID (8000 MW) (UNII: 73861X4K5F) POLYSORBATE 80 (UNII: 6OZP39ZG8H) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) PROPYLPARABEN (UNII: Z8IX2SC1OH) SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L) TARTARIC ACID (UNII: W4888I119H) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:83658-011-01 1 mg in 1 POUCH; Type 0: Not a Combination Product 11/20/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 11/20/2023 Labeler - Sj Incorporation Ltd (119051828) Registrant - Sj Incorporation Ltd (119051828)