FDA.reportPublic FDA data

HAND SANITIZER

Manufacturer
FARMACIA SAN ARCANGEL, S.A DE C.V
Effective date
2020-10-29
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:32:38

Label at a glance#

ProductHAND SANITIZER
Active ingredientALCOHOL
Label structure12 sections

Indications and uses

Hand sanitizer to decrease bacteria on the skin that could cause disease Recommended for repetead use

Dosage and administration

put enough product in your palm to cover hands and rub hands together briskly until dry without wiping for children uncer 6 years of age should be supervised when using not recommended for infants

Storage and handling

Store below 105 F (40 c) may discolour certain fabrics harmful to wood finishes and plastics

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Alcohol v/v 70%

Purposes

OTC - PURPOSE SECTION

Antimicrobial

Uses

INDICATIONS & USAGE SECTION

Hand sanitizer to decrease bacteria on the skin that could cause disease

Recommended for repetead use

Warnings

WARNINGS SECTION

for external use only: hands

flammable, keep away from fire and flame

When using this product

OTC - DO NOT USE SECTION

keep out of eyes, do not use in or near eyes.

-in case of contact with eyes flush thorougly with water

-avoid contact with broken skin

-do not inhale or ingest

when using this product

OTC - WHEN USING SECTION

keep out of eyes, do not use in or near eyes.

-in case of contact with eyes flush thorougly with water

-avoid contact with broken skin

-do not inhale or ingest

Stop use and ask a doctor if

OTC - STOP USE SECTION

Irritation and redness develop

Condition persists for more than 72 hours

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 in your palm to cover hands and rub hands together briskly until dry without wiping

for children uncer 6 years of age should be supervised when using

not recommended for infants

Other information

STORAGE AND HANDLING SECTION

Store below 105 F (40 c)

may discolour certain fabrics

harmful to wood finishes and plastics

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Purified water (aqua), Vegetable glycerin, Hydroxipropyl methylcellulose, carboxymethyl cellulose

Principal Display

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

label 20 Llabel 20 LHand sanitizer gel

eliminates 99.9% of germs

70% alcohol

Natural ingredients hands soft

Contains moisturizers

640 fl oz/ 20 L

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
80535-0004-12022-01-28C16284748780-1d6a99b39-978f-a426-e053-dadaa90af4c2b2d495df-a36f-b247-e053-2995a90a7baa

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80535-0004-1HAND SANITIZER20000 mL in 1 DRUMGEL200001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80535-0004HAND SANITIZER (ALCOHOL) GEL [FARMACIA SAN ARCANGEL, S.A DE C.V]1Legacy NDC, 1 package rows20201030_b2d495df-a36f-b247-e053-2995a90a7baa.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
80535-000480535-0004-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
CARBOXYMETHYLCELLULOSE05JZI7B19XIACT
HYPROMELLOSE 2208 (60000 MPA.S)2F7T07H9ZDIACT
ALCOHOL3K9958V90MACTIB
GLYCERINPDC6A3C0OXIACT

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
b2d495df-a370-b247-e053-2995a90a7baab2d495df-a36f-b247-e053-2995a90a7baa2020-10-29WarningsExact identifier
spl id: b2d495df-a370-b247-e053-2995a90a7baa
spl set id: b2d495df-a36f-b247-e053-2995a90a7baa

Reported adverse events (FAERS/openFDA)#

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