FDA.reportPublic FDA data

Antiseptic Hand Sanitizer

Manufacturer
Poliformas S.A. de C.V.
Effective date
2020-08-12
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:24:35

Label at a glance#

ProductAntiseptic Hand Sanitizer
Active ingredientALCOHOL
Label structure7 sections

Dosage and administration

Wet hands thoroughly with product and allow to dry without wiping

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol 70%

Purpose

OTC - PURPOSE SECTION

Antiseptic

Use

INDICATIONS & USAGE SECTION

For hand washing to decrease bacteria on the skin

Warnings

WARNINGS SECTION

For external use only
Flammable, keep away from fire or flame.

Do not use

OTC - DO NOT USE SECTION

in the eyes

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

Wet hands thoroughly with product and allow to dry without wiping

Inactive ingredients

INACTIVE INGREDIENT SECTION

Aloe Vera Leaf Extract, Glycerin, Hydrogen Peroxide, Water

Questions or Comments:

OTC - QUESTIONS SECTION

1 (956) 568-6565

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BottleBottle

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
582753ethanol 70 % Topical SolutionPSN1
582753ethanol 0.7 ML/ML Topical SolutionSCD1
582753ethanol 70 % Topical SolutionSY1
582753ethyl alcohol 70 % Topical SolutionSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
90097-000-012022-01-28C16284748780-1d6a99b39-930e-a426-e053-dadaa90af4c2Antiseptic Hand Sanitizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
90097-000-01Antiseptic Hand Sanitizer1000 mL in 1 BOTTLELIQUID10001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
90097-000ANTISEPTIC HAND SANITIZER (ALCOHOL) LIQUID [POLIFORMAS S.A. DE C.V.]1Legacy NDC, 1 package rows20200813_acafcffd-0f4d-77a5-e053-2a95a90ae4d7.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
90097-00090097-000-01

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
ALOE VERA LEAFZY81Z83H0XIACT
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
acafd792-e595-77a9-e053-2a95a90afdd2acafcffd-0f4d-77a5-e053-2a95a90ae4d72020-08-12WarningsExact identifier
spl id: acafd792-e595-77a9-e053-2a95a90afdd2
spl set id: acafcffd-0f4d-77a5-e053-2a95a90ae4d7

Reported adverse events (FAERS/openFDA)#

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