FDA.reportPublic FDA data

HAND SANITIZER

Manufacturer
EXPORTADORA IN & OUT S DE RL DE CV
Effective date
2020-06-10
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:17:11

Label at a glance#

ProductHAND SANITIZER
Active ingredientALCOHOL
Label structure13 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 under 6 years of age should be supervised when using -Not recommended for infants

Storage and handling

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

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Ethyl 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 the 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 the 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 contro 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 under 6 years of age should be supervised when using

-Not recommended for infants

Other information

STORAGE AND HANDLING SECTION

-Store below 105F (40C)

-May discolour certain fabrics

-Harmful to wood finishes and plastics

Inactive ingredients

INACTIVE INGREDIENT SECTION

Purified water (aqua), vegetable glycerin and carboxymethyl cellulose and hydrocypropyl methylcellulose (HPMC)

PRINCIPAL DISPLAY

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LABEL 250 MLLABEL 250 MLHAND SANITIZER

KILLS 99.9% OF MOST GERMS

70% ALCOHOL VOLUME

NON STERILE SOLUTION

8.5 FL OZ (250 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
77210-0008-12022-01-28C16284748780-1d6a99b39-8e7e-a426-e053-dadaa90af4c2a7c110a7-c3d9-e3f8-e053-2995a90a4043

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
77210-0008-1HAND SANITIZER250 mL in 1 BOTTLE, PLASTICGEL2501

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
77210-0008HAND SANITIZER (ALCOHOL) GEL [EXPORTADORA IN & OUT S DE RL DE CV]1Legacy NDC, 1 package rows20200611_a7c110a7-c3d9-e3f8-e053-2995a90a4043.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
77210-000877210-0008-1

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
HYPROMELLOSE 2208 (60000 MPA.S)2F7T07H9ZDIACT
CARBOXYMETHYLCELLULOSE05JZI7B19XIACT
GLYCERINPDC6A3C0OXIACT
ALCOHOL3K9958V90MACTIB
WATER059QF0KO0RIACT

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
a7c110a7-c3da-e3f8-e053-2995a90a4043a7c110a7-c3d9-e3f8-e053-2995a90a40432020-06-10WarningsExact identifier
spl id: a7c110a7-c3da-e3f8-e053-2995a90a4043
spl set id: a7c110a7-c3d9-e3f8-e053-2995a90a4043

Reported adverse events (FAERS/openFDA)#

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