HAND SANITIZER

Manufacturer
FARMACIA SAN ARCANGEL, S.A DE C.V | FARMACIA SAN ARCANGEL S.A DE C.V
Effective date
2020-09-23
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:30:05

Label at a glance#

ProductHAND SANITIZER
Active ingredientALCOHOL
Label structure12 sections

Indications and uses

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

Dosage and administration

Put 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 15-30C (58-86F) Avoid freezing and excesive heat above 40C (104F)

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Ethyl alcohol 70% v/v

Purpose

OTC - PURPOSE SECTION

Antiseptic

Uses

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 throrugly with water

Stop use and ask a doctor

OTC - STOP USE SECTION

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

keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

if swallowed, get medical help or contact a poison control center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

Put 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

STORAGE AND HANDLING SECTION

Store between 15-30C (58-86F)

Avoid freezing and excesive heat above 40C (104F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water (aqua), Vegetable Glycerine UPC, Hudroxypropyl methylcellulose and carboxymethylcellulose.

Principal Display

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Hand sanitizer

70% alcohol

68 fl. oz. (2.1qt) (2L) label 2000 mllabel 2000 ml

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
581662ethanol 70 % Topical GelPSN1
581662ethanol 0.7 ML/ML Topical GelSCD1
581662ethanol 70 % Topical GelSY1
581662ethyl alcohol 70 % Topical GelSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
80535-0002-12022-01-28C16284748780-1d6a99b39-7bf6-a426-e053-dadaa90af4c2b000150f-3beb-2e6c-e053-2995a90a67d5

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80535-0002-1HAND SANITIZER2000 mL in 1 BOTTLE, PLASTICGEL20001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80535-0002HAND SANITIZER (ALCOHOL) GEL [FARMACIA SAN ARCANGEL, S.A DE C.V]1Legacy NDC, 1 package rows20200924_b000150f-3beb-2e6c-e053-2995a90a67d5.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
80535-000280535-0002-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 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
b000150f-3bec-2e6c-e053-2995a90a67d5b000150f-3beb-2e6c-e053-2995a90a67d52020-09-23WarningsExact identifier
spl id: b000150f-3bec-2e6c-e053-2995a90a67d5
spl set id: b000150f-3beb-2e6c-e053-2995a90a67d5

Reported adverse events (FAERS/openFDA)#

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