FDA.reportPublic FDA data

Hand sanitizer

Manufacturer
INOVAKER LAB S.A. DE C.V. | INOVAKER LAB S.A. DE C.V
Effective date
2020-12-31
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-01 22:58:15

Label at a glance#

ProductHand sanitizer
Active ingredientISOPROPYL ALCOHOL
Label structure16 sections

Dosage and administration

Place 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

Label contents#

Full prescribing information#

Directions

DOSAGE & ADMINISTRATION SECTION

Place 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

Warnings

WARNINGS SECTION

For external use only. Flammable. Keep away from heat of flame

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water (aqua), glycerin, triethanolamine, carbomer, fragrance.

Use(s)

INDICATIONS & USAGE SECTION

Health care personnel hand rub to help reduce bacteria that potentially can cause disease.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away

Purpose

OTC - PURPOSE SECTION

Hand sanitizer. Antiseptic

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Isopropyl alcohol 75% v/v

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 eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

60 mL NDC: 77271-001-01 Hand sanitizerHand sanitizer

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

250 mL NDC: 77271-001-02 Hand sanitizer 250 mLHand sanitizer 250 mL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

500 mL NDC: 77271-001-03 hand sanitizer 500 mLhand sanitizer 500 mL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

750 mL 77271-001-04 hand sanitizer 750 mLhand sanitizer 750 mL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

1000 mL NDC: 77271-001-05 hand sanitizer 1000 mLhand sanitizer 1000 mL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

4000 mL NDC: 77271-001-06 hand sanitizer 4000 mLhand sanitizer 4000 mL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Hand SaniitizerHand Saniitizer120ml NDC: 77271-001-01

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
77271-00177271-001-01, 77271-001-02, 77271-001-03, 77271-001-04, 77271-001-05, 77271-001-06

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
ISOPROPYL ALCOHOLND2M416302ACTIB
WATER059QF0KO0RIACT
POLYACRYLIC ACID (8000 MW)73861X4K5FIACT
TROLAMINE9O3K93S3TKIACT
FRAGRANCE LAVENDER & CHIA F-153480SXS9CO2TZKIACT
GLYCERINPDC6A3C0OXIACT

Source Document#

Source XML · Source PDF

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
d4773cdc-5aaa-4756-e053-2995a90ae86fa4d749b1-07e5-fef8-e053-2a95a90a87d72021-12-31WarningsExact identifier
spl set id: a4d749b1-07e5-fef8-e053-2a95a90a87d7

Reported adverse events (FAERS/openFDA)#

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