SANITIZER

Manufacturer
ACE CHEM SOLUTIONS | ACE CHEMS SOLUTIONS
Effective date
2020-06-28
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:19:57

Label at a glance#

ProductSANITIZER ACE-SA001
Active ingredientBENZALKONIUM CHLORIDE
Label structure13 sections

Storage and handling

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

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

This sanitizer is manufactured using only the following United States Pharmacopoei (USP) grade ingredients in the preparation of the product (percentage in the final product formulation) consistent with World Health Organization (WHO):

Belzankonium Chloride (0.2% volume/volume (v/v)) in an aqueous solution).

Alcohol (isopropylic alcohol) (10% v/v)

Sterile distilled water or boiled cold water.

This firm does not add other active or inactive ingredients. Different or additional ingredients may impact the quality and potency of the product.

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium Chloride. Purpose: Antiseptic

OTC - PURPOSE SECTION

Antiseptic, Hands, Surface and Cloths Sanitizer.

INDICATIONS & USAGE SECTION

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

WARNINGS SECTION

For external use only.

OTC - DO NOT USE SECTION

in children less than 2 months of age

on open skin wounds

OTC - WHEN USING SECTION

When using this product keep out eyes, ears, 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 - STOP USE SECTION

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

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.

DOSAGE & ADMINISTRATION SECTION

Place enough product on hands or surfaces to cover all. Rub hands together untill dry.

Supervise children under 6 years of age when using this products to avoid swallowing.

STORAGE AND HANDLING SECTION

Store between 15-30C (59-86F)

Avoiding freezing and excessive heat above 40C (104F)

INACTIVE INGREDIENT SECTION

Isopropylic Alcohol, purified water USP.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

250 ml NDC: 77308-003-01

Sanitizante 8.5 OzSanitizante 8.5 Oz

1 L NDC: 77308-003-03

Sanitizante 32 OzSanitizante 32 Oz

4 L NDC: 77308-003-04

Sanitizante 135 OzSanitizante 135 Oz

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2380327benzalkonium chloride 0.2 % Topical SolutionPSN1
2380327benzalkonium chloride 2 MG/ML Topical SolutionSCD1
2380327benzalkonium chloride 0.2 % Topical SolutionSY1

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
77308-003-01SANITIZERACE-SA0010.25 L in 1 BOTTLELIQUID0.251
77308-003-03SANITIZERACE-SA0011 L in 1 BOTTLELIQUID11
77308-003-04SANITIZERACE-SA0014 L in 1 BOTTLE, PLASTICLIQUID41

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
77308-003SANITIZER ACE-SA001 (BENZALKONIUM CHLORIDE) LIQUID [ACE CHEM SOLUTIONS]1Legacy NDC, 3 package rows20200703_a92dae8a-6e86-6530-e053-2995a90a444a.zip

Products#

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

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

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
77308-00377308-003-01, 77308-003-03, 77308-003-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
a92dae8a-6e87-6530-e053-2995a90a444aa92dae8a-6e86-6530-e053-2995a90a444a2020-06-28WarningsExact identifier
spl id: a92dae8a-6e87-6530-e053-2995a90a444a
spl set id: a92dae8a-6e86-6530-e053-2995a90a444a

Reported adverse events (FAERS/openFDA)#

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