LOXYINE- lidocaine patch

Loxyine by

Drug Labeling and Warnings

Loxyine by is a Otc medication manufactured, distributed, or labeled by Sj Incorporation Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Lidocaine 4.0%

Purpose

Topical anesthetic

Uses

Temporarily 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 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.

Stop use and ask a doctor if

• Condition worsens
• 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 or skin injury, such as pain, swelling or blistering where the product was applied. 

If pregnant or breast-feeding,

ask a healthcare professional before use.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center (1800-222-1222) right away.

Directions

Adults and children 12 years of age and over: Clean and dry affected area. Remove film from patch (see illustration). Apply sticky side of patch to affected area. Use one path for up to 12 hours. Discard patch after single use. 

Children under 12 years of age: Consult a physician.

Other information

Store in a clean, dry place outside of direct sunlight. Protect from excessive moisture. 

Inactive ingredients

aluminum glycinate, glycerin, kaolin, methylparaben, polyacrylic acid, polysorbate 80, propylene glycol, propylparaben, PVP, sodium polyacrylate, tartaric acid, titanium dioxide, water. 

Questions or comments?

Toll free 1-800-587-4041 

Principal Display Panel

INGREDIENTS AND APPEARANCE

LOXYINE 
lidocaine patch

Product 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)