AG Alcohol Antiseptic

Manufacturer: Nivek Distribution, LLC.
Effective date: 2020-06-26
Label type: HUMAN OTC DRUG LABEL
Version: 2
Source: full-release
Hydrated at: 2026-05-31 23:19:11

Label at a glance#

ProductAG Alcohol Antiseptic

Active ingredientALCOHOL

Label structure11 sections

Dosage and administration

• 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.

Label contents#

Full prescribing information#

Active ingredient[s]

OTC - ACTIVE INGREDIENT SECTION

Alcohol 72% v/v

Purpose

OTC - PURPOSE SECTION

Antiseptic

Use[s]

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

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

Do not use

OTC - DO NOT USE SECTION

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

When using this product

OTC - WHEN USING SECTION

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

Stop use and ask a doctor

OTC - STOP USE SECTION

if irritation or rash occurs. These may be signs of a serious condition.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

• 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

SPL UNCLASSIFIED SECTION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

glycerin, hydrogen peroxide, purified water USP

Package Labeling

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label

Package Labeling: 8ml

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Bottle2

Package Labeling: 500ml

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Bottle3

Package Labeling: 1000ml

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Bottle4

Package Labeling: 3.785ml

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Bottle5

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
77523-000-00	2022-01-28	C162847	48780-1	d6a99b39-7615-a426-e053-dadaa90af4c2	AG Alcohol Antiseptic
77523-000-02	2022-01-28	C162847	48780-1	d6a99b39-7615-a426-e053-dadaa90af4c2	AG Alcohol Antiseptic
77523-000-16	2022-01-28	C162847	48780-1	d6a99b39-7615-a426-e053-dadaa90af4c2	AG Alcohol Antiseptic
77523-000-33	2022-01-28	C162847	48780-1	d6a99b39-7615-a426-e053-dadaa90af4c2	AG Alcohol Antiseptic
77523-000-37	2022-01-28	C162847	48780-1	d6a99b39-7615-a426-e053-dadaa90af4c2	AG Alcohol Antiseptic

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
77523-000-00	AG Alcohol Antiseptic	250 mL in 1 BOTTLE	GEL	250		2
77523-000-02	AG Alcohol Antiseptic	8 mL in 1 BOTTLE	GEL	8		2
77523-000-16	AG Alcohol Antiseptic	500 mL in 1 BOTTLE	GEL	500		2
77523-000-33	AG Alcohol Antiseptic	1000 mL in 1 BOTTLE	GEL	1000		2
77523-000-37	AG Alcohol Antiseptic	3785 mL in 1 BOTTLE	GEL	3785		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
77523-000	AG ALCOHOL ANTISEPTIC (ALCOHOL) GEL [NIVEK DISTRIBUTION, LLC.]	2	Legacy NDC, 5 package rows	20200627_a6cf3e5b-019b-30ee-e053-2995a90a0b24.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 5 matching rows.

AG Alcohol Antiseptic
ALCOHOL
GLYCERIN
HYDROGEN PEROXIDE
WATER

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
77523-000	77523-000-00, 77523-000-02, 77523-000-16, 77523-000-33, 77523-000-37

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
GLYCERIN	PDC6A3C0OX	IACT
HYDROGEN PEROXIDE	BBX060AN9V	IACT
WATER	059QF0KO0R	IACT
ALCOHOL	3K9958V90M	ACTIB

Source Document#

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
a8fbefa3-f4d2-08c3-e053-2a95a90a31b4			a6cf3e5b-019b-30ee-e053-2995a90a0b24	2020-06-26	Warnings	Exact identifier spl id: a8fbefa3-f4d2-08c3-e053-2a95a90a31b4 spl set id: a6cf3e5b-019b-30ee-e053-2995a90a0b24

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.