Loxyine

Loxyine
SPL v1
SPL
SPL Set ID cfd24059-707d-4474-8041-8fdc30b88631
Routes
TOPICAL PERCUTANEOUS TRANSDERMAL
Published
Effective Date 2023-11-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Lidocaine (4 mg)
Inactive Ingredients
Aluminium Triglycinate Glycerin Kaolin Methylparaben Polyacrylic Acid (8000 Mw) Polysorbate 80 Propylene Glycol Propylparaben Sodium Polyacrylate (8000 Mw) Tartaric Acid Titanium Dioxide Water

Identifiers & Packaging

Marketing Status
UNAPPROVED DRUG OTHER Active Since 2023-11-20

Description

Lidocaine 4.0%

Purpose

Topical anesthetic


Medication Information

Purpose

Topical anesthetic

Description

Lidocaine 4.0%

Uses

Temporarily relieves minor pain.

Warnings

For external use only

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.

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.
Active Ingredient

Lidocaine 4.0%

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

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.


Structured Label Content

Uses

Temporarily relieves minor pain.

Purpose

Topical anesthetic

Warnings

For external use only

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.

Do Not Use (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.
Active Ingredient (Active ingredient)

Lidocaine 4.0%

Other Information (Other information)

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

Inactive Ingredients (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? (Questions or comments?)

Toll free 1-800-587-4041 

Principal Display Panel

When Using This Product (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 (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, (If pregnant or breast-feeding,)

ask a healthcare professional before use.

Keep Out of Reach of Children. (Keep out of reach of children.)

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


Advanced Ingredient Data


Raw Label Data

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