ISOPROPYL ALCOHOL- isopropyl alcohol spray 
Safetec of America, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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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

Keep out of reach of children.

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

Inactive ingredients

purified water

PRINCIPAL DISPLAY PANEL – 2 oz. bottle label

NDC 61010-5500-2

Safetec

Isopropyl
Alcohol Spray

First Aid to Help
Prevent Infection in
Minor Cuts, Scrapes
and Burns.

2 fl. oz. (59.1ml)
Reorder no. 53002

PRINCIPAL DISPLAY PANEL – 2 oz. bottle label
ISOPROPYL ALCOHOL 
isopropyl alcohol spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61010-5500
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
isopropyl alcohol (UNII: ND2M416302) (isopropyl alcohol - UNII:ND2M416302) isopropyl alcohol70 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
water (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61010-5500-259.1 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product02/16/2012
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A02/16/2012
Labeler - Safetec of America, Inc. (874965262)
Establishment
NameAddressID/FEIBusiness Operations
Safetec of America, Inc.874965262MANUFACTURE(61010-5500)

Revised: 9/2020
Document Id: 7a585a17-5285-438a-81d6-8870efcab276
Set id: 89310a64-c4cc-46c6-8294-c4d28cd88118
Version: 3
Effective Time: 20200928
 
Safetec of America, Inc.