Indagel Max Hand Sanitizer

Indagel Max Hand Sanitizer by

Drug Labeling and Warnings

Indagel Max Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by INDALABOR INDAIA LABORATORIO FARMACEUTICO LTDA. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

INDAGEL MAX HAND SANITIZER- alcohol gel 
INDALABOR INDAIA LABORATORIO FARMACEUTICO LTDA

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Indagel Max Hand Sanitizer

Drug Facts

Active Ingredient

Ethyl Alcohol 70% v/v

Purpose

Antiseptic

Uses

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

Warnings:

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

Avoid direct contact with eyes

and mucous membranes.

Stop use and ask a doctor

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

Keep out of reach of children.

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

DO NOT SWALLOW

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

Directions

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

Inactive Ingredients

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

Other Information.

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

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

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

MADE BY: INDALABOR

INDAIÁ LABORATÓRIO FARMACÊUTICO LTDA

Dores do Indaiá, MG - 35610-000

+55 31 3377-8833

MADE IN BRAZIL

NDC: 80342-000-01

NDC: 80342-000-02

NDC: 80342-000-03

NDC: 80342-000-04

INDAGEL MAX HAND SANITIZER 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 80342-000
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	0.7 mL  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 809Y72KV36)
ISOPROPANOLAMINE (UNII: UE40BY1BZW)
DENATONIUM BENZOATE ANHYDROUS (UNII: M5BA6GAF1O)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80342-000-01	60 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	09/16/2020	12/31/2020
2	NDC: 80342-000-02	100 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	09/16/2020	12/31/2020
3	NDC: 80342-000-03	250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	09/16/2020	12/31/2020
4	NDC: 80342-000-04	500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	09/16/2020	12/31/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	09/16/2020	12/31/2020

Labeler - INDALABOR INDAIA LABORATORIO FARMACEUTICO LTDA (897123209)

Registrant - INDALABOR INDAIA LABORATORIO FARMACEUTICO LTDA (897123209)

Revised: 8/2021

Document Id: cad1dd42-d3b0-ee1c-e053-2995a90a425e

34390-5

Set id: af756785-4f04-e703-e053-2a95a90a0208

Version: 3

Effective Time: 20210830

 

INDALA