FDA.reportPublic FDA data

Indagel Max Hand Sanitizer

Manufacturer
INDALABOR INDAIA LABORATORIO FARMACEUTICO LTDA
Effective date
2020-10-08
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 23:12:33

Label at a glance#

ProductIndagel Max Hand Sanitizer
Active ingredientALCOHOL
Label structure8 sections

Indications and uses

Hand Sanitizer to help decrease bacteria and germs on the skin.

Dosage and administration

Topical use. Apply the gel directly on the skin, spreading it gently through circular movements, until complete absorption.

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol 70% v/v

Purpose

OTC - PURPOSE SECTION

Antiseptic

Uses

INDICATIONS & USAGE SECTION

Hand Sanitizer to help decrease bacteria and germs on the skin.

Warnings:

WARNINGS SECTION

Flammable Product. Keep away from source of heat, fire, or flame.

Avoid direct contact with eyes

OTC - WHEN USING SECTION

and mucous membranes.

Stop use and ask a doctor

WARNINGS AND PRECAUTIONS SECTION

if irritation or readness devolops.
Do not ingest the product. Flammable product can cause burns.

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.

DO NOT SWALLOW

WARNINGS AND PRECAUTIONS SECTION

- contains denaturing. The product contains DENATONIUM BENZOATE as a denaturant.

Directions

DOSAGE & ADMINISTRATION SECTION

Topical use. Apply the gel directly on the skin, spreading it gently through circular movements, until complete absorption.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Aqua (water), Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Alcohol, Glycerin, Isopropanolamine, and Denatonium Benzoate.

Other Information.

SPL UNCLASSIFIED SECTION

Keep in cool place and protected from sunlight. Keep the product in its original packing. Do not spill over fire.

OTC - QUESTIONS SECTION

​Questions or Comments: indalabor@indalabor.com.br

Package 60ml/100ml/250ml/500ml

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

MADE BY: INDALABOR

INDAIÁ LABORATÓRIO FARMACÊUTICO LTDA

Dores do Indaiá, MG - 35610-000

+55 31 3377-8833

MADE IN BRAZIL

NDC 80342-000-01

INDMAX060MLINDMAX060ML

NDC 80342-000-02

INDMAX100MLINDMAX100ML

NDC 80342-000-03

INDMAX250MLINDMAX250ML

NDC 80342-000-04

INDMAX500MLINDMAX500ML

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
80342-00080342-000-01, 80342-000-02, 80342-000-03, 80342-000-04

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
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)809Y72KV36IACT
ISOPROPANOLAMINEUE40BY1BZWIACT
DENATONIUM BENZOATE ANHYDROUSM5BA6GAF1OIACT
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
cad1dd42-d3b0-ee1c-e053-2995a90a425eaf756785-4f04-e703-e053-2a95a90a02082021-08-30WarningsExact identifier
spl set id: af756785-4f04-e703-e053-2a95a90a0208

Reported adverse events (FAERS/openFDA)#

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