CAPSAICIN and MENTHOL, UNSPECIFIED FORM

FDA Drug Profile — Ultimate Topical Pain Relief Patch

Drug Details

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

Indications and Usage

Directions Adults and children 12 and over apply to affected area; change patch 1 to 2 times daily Children under 12 years: Consult physician before use.

Warnings

Warnings For external useonly. Avoid contact with eyes and mucous membranes. Do not use on wounds or damaged skin. Do not cover with bandage. Do not use if you are allergic to Menthol. Consult physician for use on children under 12. Stop use and ask a doctor if conditions worsen, if symptoms persist for more than 7 days or clear up and occur again with a few days, or if a rash, itching or excessive skin irritation occurs. 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.