Cold Therapy Gel

FDA Drug Profile — X-Treme Freeze

Drug Details

Generic Name
Cold Therapy Gel
Brand Names
X-Treme Freeze
Application Number
M017
Sponsor
Dynarex Corporation
NDC Codes
1
Dosage Forms
GEL
Routes
TOPICAL
Active Ingredients
MENTHOL

Indications and Usage

Use(s) • Temporary relief from minor aches and pains of sore muscles and joints associated with arthritis, backache, strains, and sprains • Provides penetrating pain relief

Warnings

Warnings For External Use Only When using this product • Avoid contact with eyes • Do not apply to wounds or damaged skin • Do not bandage tightly Stop use and ask a doctor if: • Condition worsens • Symptoms last more than 7 days or clear up and occur again within a few days, discontinue use of this product If pregnant or breast feeding: Ask a health professional before use. Keep out of reach of children If swallowed, get medical help. Contact a physician or Poison Control Center (1-800-222-1222) right way.