Isopropyl Alcohol by Provision Medical / Safetec of America, Inc. ISOPROPYL ALCOHOL spray

Isopropyl Alcohol by

Drug Labeling and Warnings

Isopropyl Alcohol by is a Otc medication manufactured, distributed, or labeled by Provision Medical, Safetec of America, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients

Isopropyl Alcohol 70.0%

Purpose

First Aid Antiseptic

Uses

First aid to help prevent infection in minor cuts, scrapes and burns

Warnings

For external use only. Flammable keep away from fire or flame

Do not use

• near eyes or mucous membranes
• on deep or puncture wounds, animal bites, or serious burns consult a physician

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Caution

• not for use on large areas of the body
• if redness, irritation, swelling or pain persists or increases, discontinue use and consult a physician

Directions

• spray over cleaned affected area 1 to 3 times daily
• if bandaged, let dry first

Inactive ingredients

purified water

Principal Display Panel - Bottle Label

ISOPROPYL
ALCOHOL

Caution: Flammable

For External Use Only - If Taken Internally
Serious Gastric Disturbances Will Result

Package Not Child Resistant

2 fl. oz. (59.15ml)

Manufactured for

Provision Medical Products Palm Desert, CA 92211

INGREDIENTS AND APPEARANCE

ISOPROPYL ALCOHOL 
isopropyl alcohol spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69103-3502
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
isopropyl alcohol (UNII: ND2M416302) (isopropyl alcohol - UNII:ND2M416302)	isopropyl alcohol	700 mL  in 1 L

Inactive Ingredients
Ingredient Name	Strength
water (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69103-3502-1	0.05915 L in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	08/29/2014

Labeler - Provision Medical (036936831)

Registrant - Safetec of America, Inc. (874965262)

Establishment
Name	Address	ID/FEI	Business Operations
Safetec of America, Inc.		874965262	MANUFACTURE(69103-3502)