ISOPROPYL ALCOHOL ANTISEPTIC HAND SANITIZER NON-STERILE- isopropyl alcohol solution 
SpecGx LLC

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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4020 Isopropyl Alcohol Antiseptic 75%

Drug Facts
Active ingredient(s)

Isopropyl Alcohol 75% v/v.

Purpose

Antiseptic

Use(s)

Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Warnings

For external use only. Flammable. Keep away from heat or flame.

Do not use

  • in children less than 2 months of age
  • on open skin wounds

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

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

Directions

  • Place enough product on hands to cover all surfaces. Rub hands together until dry.
  • Supervise children under 6 years of age when using this product to avoid swallowing.

Other information

  • Store between 15-30ºC (59-86ºF)
  • Avoid freezing and excessive heat above 40ºC (104ºF)

Inactive ingredients

glycerin, hydrogen peroxide, purified water USP

SpecGx LLC
3600 N. Second St.
St. Louis, MO 63147 USA
1-314-654-2000

Rev: 04/2020

Principal Display Panel

Code 4020F
Code 4020B
ISOPROPYL ALCOHOL ANTISEPTIC HAND SANITIZER NON-STERILE 
isopropyl alcohol solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0406-4020
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL75 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX)  
HYDROGEN PEROXIDE (UNII: BBX060AN9V)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0406-4020-253785.41 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/30/202003/31/2022
2NDC:0406-4020-26946.35 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/30/202003/31/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart333A03/30/202003/31/2022
Labeler - SpecGx LLC (080679498)

Revised: 3/2022
Document Id: b9fb0329-f0c7-49cb-9595-47dab4769cc2
Set id: 4abb07eb-ad4a-4353-ae7d-7fd8f3428cff
Version: 4
Effective Time: 20220321
 
SpecGx LLC