Camphor (Synthetic), Levomenthol, and Capsicum

FDA Drug Profile — TIGER BALM PAIN RELIEVING, TIGER BALM PAIN RELIEVING HYDROGEL, TIGER Balm PAIN RELIEVING HYDROGEL

Drug Details

Generic Name
Camphor (Synthetic), Levomenthol, and Capsicum
Brand Names
TIGER BALM PAIN RELIEVING, TIGER BALM PAIN RELIEVING HYDROGEL, TIGER Balm PAIN RELIEVING HYDROGEL
Application Number
M017
Sponsor
Haw Par Healthcare Ltd.
NDC Codes
3
Dosage Forms
PATCH
Routes
TOPICAL
Active Ingredients
CAMPHOR (SYNTHETIC), CAPSICUM, LEVOMENTHOL

Indications and Usage

Uses For temporary relief of pains.

Warnings

Warnings FOR EXTERNAL USE ONLY When using this product Use only as directed Do not get into eyes or on mucous membranes Do not apply to wounds, damaged or irritated skin Do not bandage or cover with any type of wrap except clothing Do not use with a heating pad or apply external heat Do not use 1 hour prior to bathing or within 30 minutes after bathing Stop use and ask a doctor if Condition worsens Severe skin irritation occurs Pain persists for more than 7 days Symptoms clear up and occur again within a few days If pregnant or breast-feeding, or if you have sensitive skin, ask a healthcare professional before use. Keep out of reach of children. If swallowed, get medical help or contact Poison Control Center right away.