ProStat Cold Spray by ProStat First Aid PROSTAT COLD SPRAY-

ProStat Cold Spray by

Drug Labeling and Warnings

ProStat Cold Spray by is a Other medication manufactured, distributed, or labeled by ProStat First Aid. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Isobutane
N-Butane
Propane

Purpose

Topical Coolant
Topical Coolant
Topical Coolant

Uses

First aid to help

minor pain and swelling from sprains, bruising, and contusion
minor sports injuries 

Warnings

For external use only

Flammable
keep away from fire or flame
contents under pressure
do not puncture or incinerate container
do not expose to temperatures above 120° F 

Do not use

in or near eyes or other mucous membranes
in case of serious burns
in deep puncture wounds
for a prolonged period of time
on a large portion of the body 

Stop use and ask a doctor if

redness, swelling or irritation occurs
infection occurs
condition worsens
symptoms persist for more than 7 days 

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

hold can 4-6 inches away from treatment area, using a sweeping motion
spray area until skin just turns white
do not spray after skin turns white 

Other information

avoid inhaling
use only as directed
intentional misuse by deliberately concentrating and inhaling the contents may be harmful or fatal 

Principal Display

INGREDIENTS AND APPEARANCE

PROSTAT COLD SPRAY 
refrigerant, topical (vapocoolant)

Product Information
Product Type	OTC MEDICAL DEVICE	Item Code (Source)	NHRIC:58228-0101

Other Ingredients
Ingredient Kind	Ingredient Name	Quantity
INGR	ISOBUTANE (UNII: BXR49TP611)
INGR	BUTANE (UNII: 6LV4FOR43R)
INGR	PROPANE (UNII: T75W9911L6)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NHRIC:58228-0101-4	113 g in 1 BOTTLE, SPRAY

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
premarket notification	K033720	02/18/2014

Labeler - ProStat First Aid (061263699)