FDA.reportPublic FDA data

HAND SANITIZER

Manufacturer
EXPORTADORA IN & OUT S DE RL DE CV
Effective date
2020-05-05
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:09:50

Label at a glance#

ProductHAND SANITIZER
Active ingredientALCOHOL
Label structure14 sections

Indications and uses

- Hand sanitizer to decrease virus and bacteria on the skin that could cause disease -Recomended for repeated use

Dosage and administration

-Put enough product in your palm to cover hands and rub hands together briskly until dry without wiping -For children under 6 years of age should be supervised when using OZO -Not recommended for infants

Storage and handling

-Store below 105 F (40 C) -May discolor certain fabrics -Harmful to wood finishes and plastics

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Alcohol 70% v/v. Porpuse: Antimicrobial

Purpose

OTC - PURPOSE SECTION

Antimicrobial

uses

INDICATIONS & USAGE SECTION

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

-Recomended for repeated use

warnings

WARNINGS AND PRECAUTIONS SECTION

For external use only: hands

Flammable, keep away from fire or flame.

Stop use and ask a doctor if

OTC - DO NOT USE SECTION

-irritation and redness develop

-condition persist for more than 72 hours. Keep out of reach of childre. If swallowed, get medical help or contact a Poison Control Center right away

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

when using this product

OTC - WHEN USING SECTION

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

In case of contact with eyes, flush thoroughly with water

avoid contact with broken skin

do not inhale or ingest

Directions

INDICATIONS & USAGE SECTION

-Put enough product in your palm to cover hands and rub hands together briskly until dry without wiping

-For children under 6 years of age should be supervised when using OZO

-Not recommended for infants

Other information

STORAGE AND HANDLING SECTION

-Store below 105 F (40 C)

-May discolor certain fabrics

-Harmful to wood finishes and plastics

Inactive ingredients

INACTIVE INGREDIENT SECTION

Purified water (Aqua), Vegetable Glycerin, and Carboxymethyl cellulose

directions

DOSAGE & ADMINISTRATION SECTION

-Put enough product in your palm to cover hands and rub hands together briskly until dry without wiping

-For Children under 6 years of age should be supervised when using OZO

-Not recommended for infants

Warnings

WARNINGS SECTION

For external use only: hands

Flammable, keep away from fire or flame

principal display

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

33.8 FL OZ (1 Liter)33.8 FL OZ (1 Liter)efficiently kills 99.9% of most illnes causing germs

OZONE

hand sanitizer gel

antibacterial ozonized gel

luxury formula

leaves hands soft

contain moisturizers

paraben free

phthalate free

formaldehyde donor free

33.8 FL OZ (1 Liter)

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
77210-0001-12022-01-28C16284748780-1d6a99b39-3d13-a426-e053-dadaa90af4c2a4ef357d-5486-b47d-e053-2a95a90a818d

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
77210-0001-1HAND SANITIZER1000 mL in 1 BOTTLE, DISPENSINGGEL10001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
77210-0001HAND SANITIZER (ALCOHOL) GEL [EXPORTADORA IN & OUT S DE RL DE CV]1Legacy NDC, 1 package rows20200506_a4ef357d-5486-b47d-e053-2a95a90a818d.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
77210-000177210-0001-1

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
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MACTIB
CARBOXYMETHYLCELLULOSE05JZI7B19XIACT
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
a4ef357d-5487-b47d-e053-2a95a90a818da4ef357d-5486-b47d-e053-2a95a90a818d2020-05-05WarningsExact identifier
spl id: a4ef357d-5487-b47d-e053-2a95a90a818d
spl set id: a4ef357d-5486-b47d-e053-2a95a90a818d

Reported adverse events (FAERS/openFDA)#

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