Cool n Heat

FDA Drug Profile — Cool n Heat

Drug Details

Generic Name
Cool n Heat
Brand Names
Cool n Heat
Application Number
M017
Sponsor
NeilMed Pharmaceuticals, Inc.
NDC Codes
1
Dosage Forms
SPRAY
Routes
TOPICAL
Active Ingredients
MENTHOL

Indications and Usage

Indication & Usage temporarily relief of pain and itching associated with arthritis simple backache muscle strains bruises cramps muscle sprains

Warnings

Warnings: For external use only. Flammable: Do not use while smoking or near heat or flames. Avoid long term storage above 104°F. Do not puncture or incinerate. Contents under pressure. Do not store at temperatures above 120°F. When using this product avoid contact with eyes and mucous membranes. Do not apply to wounds or damaged skin. Do not bandage tightly. Use only as directed. Stop use and ask doctor if condition worsens or symptoms persist for more than 7 days or clear up and occur again within a few days. Do not use for longer than 1 week. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately. If pregnant or breast-feeding, ask a health professional before use.