LIDOCAINE and MENTHOL, UNSPECIFIED FORM

FDA Drug Profile — Lidocaine Pain Relief Patch

Drug Details

Generic Name
LIDOCAINE and MENTHOL, UNSPECIFIED FORM
Brand Names
Lidocaine Pain Relief Patch
Application Number
part348
Sponsor
Foshan Aqua Gel Biotech Co.,Ltd.
NDC Codes
1
Dosage Forms
PATCH
Routes
TOPICAL
Active Ingredients
LIDOCAINE, MENTHOL, UNSPECIFIED FORM

Indications and Usage

Directions Adults and children over 12 years of age: clean and dry affected area strip off the clear protective film and place adhesive patch over affected area leave in place for up to 8 hours wash hands thoroughly after applying or removing patch. Children under 12 years: ask a doctor before use.

Warnings

Warnings For external use only Avoid contact with eyes. Do not use if you are allergic to any active and inactive ingredients listed in this patch if pouch is damaged or opened on raw surfaces or blistered areas, open wounds, or on damaged, cut, irriated or sensitive skin for more than one week without consulting a doctor. When using this product use only as directed. Read and follow all directions and warnings on this package do not allow contact with eyes or mucous membranes 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 do not reuse patch dispose of used patch in manner that always keeps product away from children or 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 conditions worsens rash, itching or skin irritation develops symptoms persist for more than 7 days or clear up and occurs again within a few days you experience signs of skin injury, such as pain, swelling, or blistering where the product was applied. If pregnant or breast feeding ask a health professional before use. Keep out of reach of children If swallowed, get medical help or contact a Poison Control Center right away.