Topical Analgesic

FDA Drug Profile — Pain Relief Roll On, DentiCalm

Topical Analgesic is listed in the FDA National Drug Code directory with 2 NDC codes, marketed under brand names including Pain Relief Roll On, DentiCalm. Available dosage forms: liquid, emulsion.

Drug Details

Generic Name
Topical Analgesic
Brand Names
Pain Relief Roll On, DentiCalm
Application Number
M017
Sponsor
Eagle Labs Inc
NDC Codes
2
Dosage Forms
LIQUID, EMULSION
Routes
TOPICAL
Active Ingredients
MENTHOL, CAMPHOR (SYNTHETIC), CAPSAICIN

Indications and Usage

Usage Temporary relief from minor aches and pains of sore muscles and joints associated with teeth grinding and clenching (bruxism)

Warnings

Warnings For External Use Only When using this product: [bullet] Avoid contact with eyes and mucous membranes [bullet] Do not apply to wounds or broken skin [bullet] Do not bandage [bullet] Do not apply to irritated skin or if excessive skin irritation develops Stop use and ask a doctor if conditions worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and consult a doctor.