FDA Label for Satohap Lidocaine 4% Pain Relieving Pad
View Indications, Usage & Precautions
Satohap Lidocaine 4% Pain Relieving Pad Product Label
The following document was submitted to the FDA by the labeler of this product Sato Pharmaceutical Co., Ltd.. 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 analgesic
Uses
For temporary relief of pain
Warnings
For external use only.
Do Not Use
- more than 1 patch at a time
- on wounds or damaged skin
- with a heating pad
- if you are allergic to any ingredients of this product
- in large quantities, particularly over raw surfaces or blistered areas
When Using This Product
- use only as directed. Read and follow all directions and warnings on this carton.
- avoid contact with the eyes, mucous membranes or rashes
- do not bandage tightly or apply local heat (such as heating pads) to the area of use
- do not use at the same time as other topical analgesics
- 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
- localized skin reactions occur, such as rash, itching, redness, irritation, pain, swelling and blistering
- symptoms persist for more than 7 days or clear up and occur again within a few days
Keep Out Of Reach Of Children And Pets.
If swallowed, get medical help or contact a poison Control Center right away.
Directions
adults and children over 12 years:
- clean and dry affected area
- peel off protective backing and apply sticky side to affected area
- use 1 patch for up to 8 hours
children 12 years or younger: ask a doctor
Other Information
- avoid storing product in direct sunlight
- protect product from excessive moisture
- store at 68°-77°F (20°-25°C)
Inactive Ingredients
carboxymethylcellulose sodium, diethylene glycol monoethyl ether, dihydroxyaluminum aminoacetate, edetate disodium, gelatin, glycerin, methylparaben, partially neutralized polyacrylate, phosphoric acid, polysorbate 80, polyvinyl alcohol, propylene glycol, propylparaben, sorbitol, tartaric acid, urea, water, on a breathable polyester fabric with a removable polypropylene protective cover
Satohap Lidocaine 4% Pain Relieving Pad
* Please review the disclaimer below.