Clean Sept Alcohol Antiseptic 70% Hand Sanitizer

Manufacturer: BE FACTORY LABORATORIES INDUSTRIA COMERCIO IMPORTACAO E EXPORTACAO LTDA
Effective date: 2020-12-07
Label type: HUMAN OTC DRUG LABEL
Version: 2
Source: full-release
Hydrated at: 2026-05-31 23:34:43

Label at a glance#

ProductClean Sept Alcohol Antiseptic 70% Hand Sanitizer

Active ingredientALCOHOL

Label structure8 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.

Storage and handling

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

Label contents#

Full prescribing information#

Drug Facts Panel - Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Denatured Ethyl Alcohol 70% w/w. Purpose: Antiseptic.

Drug Facts Panel - Purpose

OTC - PURPOSE SECTION

Purpose: Antiseptic

Drug Facts Panel - Use

INDICATIONS & USAGE SECTION

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

Drug Facts Panel - Warnings

WARNINGS SECTION

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.

OTC - DO NOT USE SECTION

Do not use
● in children less than 2 months of age
● on open skin wounds

OTC - WHEN USING SECTION

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

OTC - STOP USE SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Drug Facts Panel - 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.

Drug Facts Panel - Other Information

STORAGE AND HANDLING SECTION

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

Drug Facts Panel - Inactive Ingredients

INACTIVE INGREDIENT SECTION

Water.

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

5000 ml, NDC 79916-002-01

Label 5L

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
582753	ethanol 70 % Topical Solution	PSN	2
582753	ethanol 0.7 ML/ML Topical Solution	SCD	2
582753	ethanol 70 % Topical Solution	SY	2
582753	ethyl alcohol 70 % Topical Solution	SY	2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
79916-002-01	2022-01-28	C162847	48780-1	d6a99b39-65ff-a426-e053-dadaa90af4c2	NO CHANGES NOTIFICATION

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
79916-002-01	Clean Sept Alcohol Antiseptic 70% Hand Sanitizer	5000 mL in 1 JUG	LIQUID	5000		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
79916-002	CLEAN SEPT ALCOHOL ANTISEPTIC 70% HAND SANITIZER (ETHYL ALCOHOL) LIQUID [BE FACTORY LABORATORIES INDUSTRIA COMERCIO IMPORTACAO E EXPORTACAO LTDA]	2	Legacy NDC, 1 package rows	20201208_ac348710-f017-d852-e053-2995a90a5356.zip

Products#

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

DailyMed product names page 1 of 1 · 4 matching rows.

Clean Sept Alcohol Antiseptic 70% Hand Sanitizer
Ethyl Alcohol
ALCOHOL
WATER

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
79916-002	79916-002-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
ALCOHOL	3K9958V90M	ACTIB
WATER	059QF0KO0R	IACT

Source Document#

Source XML

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
b5e134be-a289-edec-e053-2a95a90aadce			ac348710-f017-d852-e053-2995a90a5356	2020-12-07	Warnings	Exact identifier spl id: b5e134be-a289-edec-e053-2a95a90aadce spl set id: ac348710-f017-d852-e053-2995a90a5356

Reported adverse events (FAERS/openFDA)#

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