Liquid Hand Sanitizer by Durant Engineering

Liquid Hand Sanitizer by

Drug Labeling and Warnings

Liquid Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Durant Engineering. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

LIQUID HAND SANITIZER- isopropyl alcohol liquid 
Durant Engineering

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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Active Ingredient(s)

Isopropyl Alcohol 75% v/v. Purpose: Antiseptic

Purpose

antiseptic, hand sanitizer

Use

Hand Sanitizer to help reduce bacteria that potentially can cause disease.

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 mouth, eyes, and ears. In case of contact with eyes, rinse eyes thoroughly with water.

Stop use if irritation or rash occurs and ask a doctor. 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.

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.

Inactive ingredients

glycerin, hydrogen peroxide, water

Package Label - Principal Display Panel

118 ml NDC: 80186-1014-1

LIQUID HAND SANITIZER 
isopropyl alcohol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 80186-1014
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302)	ISOPROPYL ALCOHOL	75 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)	1.45 mL  in 100 mL
HYDROGEN PEROXIDE (UNII: BBX060AN9V)	0.125 mL  in 100 mL
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80186-1014-1	118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	09/14/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	09/14/2020	02/01/2021

Labeler - Durant Engineering (107517944)

Establishment
Name	Address	ID/FEI	Business Operations
Durant Engineering		107517944	manufacture(80186-1014) , label(80186-1014)

Revised: 11/2022

Document Id: eebaff67-e5b5-661c-e053-2a95a90a698e

34390-5

Set id: af8d9b4f-2cda-0c24-e053-2a95a90a46d7

Version: 3

Effective Time: 20221130