ProStat Cold Spray

Manufacturer: ProStat First Aid
Effective date: 2014-02-24
Label type: OTC MEDICAL DEVICE LABEL
Version: 2
Source: full-release
Hydrated at: 2026-06-01 02:47:52

Label at a glance#

ProductProStat Cold Spray

Label structure9 sections

Indications and uses

First aid to help minor pain and swelling from sprains, bruising, and contusion minor sports injuries

Dosage and administration

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

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Isobutane
N-Butane
Propane

Purpose

OTC - PURPOSE SECTION

Topical Coolant
Topical Coolant
Topical Coolant

Uses

INDICATIONS & USAGE SECTION

First aid to help

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

Warnings

WARNINGS SECTION

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

OTC - DO NOT USE SECTION

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

OTC - STOP USE SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

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

OTHER SAFETY INFORMATION

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

Principal Display

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image description

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
58228-0101-4	ProStat Cold Spray	113 g in 1 BOTTLE, SPRAY		113		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
58228-0101	PROSTAT COLD SPRAY () [PROSTAT FIRST AID]	2	1 package rows	20140225_4d52f2ad-61fe-415d-8ff0-574a97982998.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 4 matching rows.

ProStat Cold Spray
ISOBUTANE
BUTANE
PROPANE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
58228-0101	58228-0101-4

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
ISOBUTANE	BXR49TP611	INGR
BUTANE	6LV4FOR43R	INGR
PROPANE	T75W9911L6	INGR

Source Document#

Source XML · Source PDF

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.