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

Alcohol Antiseptic Hand Sanitizer Non-sterile by

Drug Labeling and Warnings

Alcohol Antiseptic Hand Sanitizer Non-sterile by is a Otc medication manufactured, distributed, or labeled by SpecGx LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug FactsActive ingredient(s)

Isopropyl Alcohol 80% 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

QUESTIONS

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

Rev: 03/2020

Principal Display Panel

INGREDIENTS AND APPEARANCE

ISOPROPYL ALCOHOL ANTISEPTIC HAND SANITIZER NON-STERILE 
isopropyl alcohol solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0406-4021
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302)	ISOPROPYL ALCOHOL	80 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
HYDROGEN PEROXIDE (UNII: BBX060AN9V)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0406-4021-25	3785.41 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/30/2020
2	NDC: 0406-4021-26	946.35 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/30/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part333A	03/03/2020

Labeler - SpecGx LLC (080679498)