FDA.reportPublic FDA data

Gel Antibacterial

Manufacturer
QUIBI S A EN REESTRUCTURACION
Effective date
2021-07-30
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 22:33:24

Label at a glance#

ProductGel Antibacterial
Active ingredientALCOHOL
Label structure11 sections

Indications and uses

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

Dosage and administration

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

Storage and handling

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

Label contents#

Full prescribing information#

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Alcohol 65% v/v Purpose: Antiseptic

Purpose

OTC - PURPOSE SECTION

Aseptic, Hand Sanitizer

Uses

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 use

- in children under 2 months of age

- in open skin wound

OTC - WHEN USING SECTION

When using this product, keep out of the eyes, ears and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

OTC - STOP USE SECTION

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away at 1-800-222-1222.

Directions

DOSAGE & ADMINISTRATION SECTION

Directions

- Place enough product on hands to cover ll surfaces. Rub hands together until dry.

- Supervise children under 6 years of age when using this product to avoid ingestion swallowing.

Other Information

STORAGE AND HANDLING SECTION

- Store between 15-30C (59-86F)

- Avoid freezing and excessive heat above 40C (104F)

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Glycerin USP, Triethanolamine USP, Purified Water USP, Carbopol

Package Label. Principal Display Panel.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Gel Antibacterial LabelGel Antibacterial LabelGel Antibacterial LabelGel Antibacterial Label

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
81815-12181815-121-44, 81815-121-51, 81815-121-48, 81815-121-43, 81815-121-47

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
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MACTIB
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
GLYCERINPDC6A3C0OXIACT
TROLAMINE9O3K93S3TKIACT

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
0d2a074e-bed0-80cf-e063-6394a90ac144c854b691-c60e-8295-e053-2a95a90abb192023-12-23WarningsExact identifier
spl set id: c854b691-c60e-8295-e053-2a95a90abb19

Reported adverse events (FAERS/openFDA)#

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