Cold Therapy Roll on

FDA Drug Profile — Cold Therapy Roll on

Drug Details

Generic Name
Cold Therapy Roll on
Brand Names
Cold Therapy Roll on
Application Number
M017
Sponsor
Allegiant Health
NDC Codes
1
Dosage Forms
GEL
Routes
TOPICAL
Active Ingredients
MENTHOL

Indications and Usage

Use(s) Temporarily relieves minor aches and pains of muscles and joints associated with: simple backache arthritis strains bruises sprains

Warnings

Warnings For external use only. Flammable: Keep away from excessive heat or open flame When using this product • use only as directed • avoid contact with mucous membranes • do not apply to wounds or damaged skin • do not apply to irritated skin or if excessive irritation develops • do not bandage tightly or use with heating pad or device • children 2 years to under 12 years of age: use only under adult supervision Stop use and ask a doctor if • you experience pain, swelling or blistering of the skin • condition worsens, or symptoms persist for more then 7 days or clear up and occur again within a few days • arthritic pain persists for more then 10 days, or redness is present, or in conditions affecting children under 12 years of age If pregnant or breastfeeding, ask a health professional before use. Keep out of reach of children If product is swallowed, get medical help or contact a Poison Control Center right away.