FDA Label for Lidocaine 4% Pain Relief Gel Patch
View Indications, Usage & Precautions
Lidocaine 4% Pain Relief Gel Patch Product Label
The following document was submitted to the FDA by the labeler of this product One2zee Limited Liability Company. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Active Ingredient
Lidocaine 4%
Purpose
Topical Anesthetic
Use
Temporarily relieves minor pain
Warnings
For external use only
Do Not Use:
- more than 1 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
- at the same time as other topical analgesics
When Using This Product:
• use only as directed.
• read and follow all directions and warnings on this label
• rare cases of serious burns have been reported with products of this type.
• do not apply to wounds or damaged, broken
• eyes and mucous membranes
• do not bandage tightly or apply local heat (such as
• the same time as other topical analgesics
• 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.
• a transient burning sensation may occur upon application but generally disappears in several days
• if a severe burning sensation occurs, discontinue use immediately.
• discontinue use at least 1 hour before a bath or shower.
• do not use immediately after a bath or shower.
Stop Use And Ask Doctor If:
• condition 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 this product is 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 right away.
Directions:
Adult and children over 12years:
- Clean and dry affected area
- remove backing from patch by firmly grasping both ends and
- gently pulling until back separates in middle
- Carefully remove smaller portion of backing from the patch and apply exposed portion of
- patch to affected area
- use 1 patch for up to 12 hours children 12 years or younger: ask a doctor
Inactive Ingredients:
Alpha Tocopherol, Aluminum Sulphate, Borax, Carbomer, Colloidal Silicon Dioxide, DMDM Hydantoin, Glycerin, Kaolin, Polyacrylic Acid, Polyvinyl Alcohol, Polyvinylpyrrolidone , Propylene Glycol, Purified Water, Sodium Carboxymethyl Cellulose, Sodium Ethylenediaminetetraacetic Acid, Sodium Polyacrylate, Sorbitol, Sorbitol Monooleate , Tartaric Acid & Titanium Dioxide, Butylated Hydroxytoluene, Polysorbate
Other Information:
Store at room temperature 20·25'C (68-77'F)
Questions? call toll-free 1-844-912-4012
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