Hand Sanitizer

Manufacturer
INNDEA, S.A. de C.V.
Effective date
2020-08-05
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:24:24

Label at a glance#

ProductHand Sanitizer
Active ingredientALCOHOL
Label structure13 sections

Dosage and administration

- Place enough product on hands to cover all surfaces. Rub hands together until dry. - Supervise children under 6 years age when using this product to avoid swallowing.

Label contents#

Full prescribing information#

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol 70% v/v

Purpose

OTC - PURPOSE SECTION

Antiseptic

Use(s)

INDICATIONS & USAGE SECTION

Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Warnings

WARNINGS SECTION

For external use only. Flammable. Keep away from heat or flame. Do not mix use with other household chemicals.

Do not use

OTC - DO NOT USE SECTION

- In children less than two months of age.
- On open skin wounds.

When using this product

OTC - WHEN USING SECTION

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

Stop use and ask a doctor

OTC - STOP USE SECTION

if irritation or rash occurs. These maybe signs of serious condititon.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a poision control center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

- Place enough product on hands to cover all surfaces. Rub hands together until dry.
- Supervise children under 6 years age when using this product to avoid swallowing.

Other information

SPL UNCLASSIFIED SECTION

- Store between 15-30C (59-86F)
- Avoid freezing and excesive heat above 40C (104F)

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Purified water, glicerin, aloe vera extract, tocopheryl acetate (vitamin E).

Questions

OTC - QUESTIONS SECTION

+52 1 55 3775 1431 8:00 AM - 5:00 PM (EAST)

Package Labeling:10ml

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BottleBottle

Package Labeling:250ml

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

250250

Package Labeling:500ml

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

500500

Package Labeling:1000ml

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

11

Package Labeling:3780ml

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

3.783.78

Package Labeling:1000L

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

10001000

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
79875-000-01Hand Sanitizer10 mL in 1 BOTTLEGEL102
79875-000-02Hand Sanitizer250 mL in 1 BOTTLEGEL2502
79875-000-03Hand Sanitizer500 mL in 1 BOTTLEGEL5002
79875-000-04Hand Sanitizer1000 mL in 1 BOTTLEGEL10002
79875-000-05Hand Sanitizer3780 mL in 1 BOTTLEGEL37802
79875-000-06Hand Sanitizer1000000 mL in 1 BOTTLEGEL10000002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79875-000HAND SANITIZER (ALCOHOL) GEL [INNDEA, S.A. DE C.V.]2Legacy NDC, 6 package rows20200812_7fcbd84a-06ba-4f48-a6c2-5a0305c13595.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
79875-00079875-000-01, 79875-000-02, 79875-000-03, 79875-000-04, 79875-000-05, 79875-000-06

Ingredients#

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

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

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
ac222700-e5b4-5f4d-e053-2a95a90ab8e07fcbd84a-06ba-4f48-a6c2-5a0305c135952020-08-05WarningsExact identifier
spl id: ac222700-e5b4-5f4d-e053-2a95a90ab8e0
spl set id: 7fcbd84a-06ba-4f48-a6c2-5a0305c13595

Reported adverse events (FAERS/openFDA)#

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