FDA.reportPublic FDA data

ANTISEPTIC DISINFECTANT

Manufacturer
Maquiladora La Central, S.A. de C.V.
Effective date
2020-07-05
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:20:10

Label at a glance#

ProductANTISEPTIC DISINFECTANT
Active ingredientALCOHOL
Label structure13 sections

Dosage and administration

Place enough product to clean the infected area Supervise children under 6 years of age when using this product to avoid swallowing.

Storage and handling

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

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

The antiseptic disinfectant is manufactured using only the following United States Pharmacopoeia (USP) grade ingredients in the preparation of the product (percentage in final product formulation) consistent with World Health Organization (WHO) recommendations:

Ethyl Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (96%, volume/volume (v/v)) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.

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

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol 96% v/v. Purpose: Antiseptic

Purpose

OTC - PURPOSE SECTION

Antiseptic

Use

INDICATIONS & USAGE SECTION

Antiseptic Disinfectant to help reduce bacteria that potentially can cause disease.

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

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.

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 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.

Directions

DOSAGE & ADMINISTRATION SECTION

Place enough product to clean the infected area
Supervise children under 6 years of age when using this product to avoid swallowing.

Other information

STORAGE AND HANDLING SECTION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

purified water USP

Maximum 1000000000 mL in 1 CONTAINER (77217-200-05)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LABEL APPROVEDLABEL APPROVED

1000 mL NDC: 77217-200-05

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
77217-200-052021-07-23C16284748780-1c7ccaba7-152a-fd44-e053-dadaa90aa01ba9b39d0d-511c-77ad-e053-2995a90a48cb

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
77217-200-05ANTISEPTIC DISINFECTANT1000 mL in 1 BOTTLELIQUID10002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
77217-200ANTISEPTIC DISINFECTANT (ETHYL ALCOHOL) LIQUID [MAQUILADORA LA CENTRAL, S.A. DE C.V.]2Legacy NDC, 1 package rows20200706_a9b39d0d-511c-77ad-e053-2995a90a48cb.zip

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
77217-20077217-200-05

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
NameUNIIKind
GLYCERINPDC6A3C0OXIACT
HYDROGEN PEROXIDEBBX060AN9VIACT
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MACTIB

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
a9bea349-7ace-7774-e053-2a95a90af15fa9b39d0d-511c-77ad-e053-2995a90a48cb2020-07-05WarningsExact identifier
spl id: a9bea349-7ace-7774-e053-2a95a90af15f
spl set id: a9b39d0d-511c-77ad-e053-2995a90a48cb

Reported adverse events (FAERS/openFDA)#

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