Fashion Antiseptic Gel Hand Sanitizer

Manufacturer
JOAO HENRIQUE SILVA BESSA E CIA LTDA
Effective date
2020-12-28
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:35:59

Label at a glance#

ProductFashion Antiseptic Gel Hand Sanitizer
Active ingredientALCOHOL
Label structure9 sections

Indications and uses

Use: 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 all surfaces. Rub hands together until dry. ● Supervise children under 6 years of age when using this product to avoid swallowing.

Storage and handling

Other information: ● Store between 15-30 °C (59-86 °F) ● Avoid freezing and excessive heat above 40 °C (104 °F)

Label contents#

Full prescribing information#

Drug Facts Panel - Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Denatured Ethyl Alcohol 70%. Purpose: Antiseptic

Drug Facts Panel - Purpose

OTC - PURPOSE SECTION

Purpose: Antiseptic.

Drug Facts Panel - Uses

INDICATIONS & USAGE SECTION

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

Drug Facts Panel - Warnings

WARNINGS SECTION

For external use only. Flammable. Keep away from heat or flame.
Do not use
● in children less than 2 months of age
● on open skin wounds
When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.
Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

OTC - DO NOT USE SECTION

Do not use
● in children less than 2 months of age
● on open skin wounds

OTC - WHEN USING SECTION

When using this product keep out of 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 - ASK DOCTOR 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.

Drug Facts Panel - Directions

INSTRUCTIONS FOR USE SECTION

Directions:

● 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.

Drug Facts Panel - Other Information

STORAGE AND HANDLING SECTION

Other information:
● Store between 15-30 °C (59-86 °F)
● Avoid freezing and excessive heat above 40 °C (104 °F)

Drug Facts Panel - Inactive Ingredients

INACTIVE INGREDIENT SECTION

Inactive ingredients:
Aminomethyl Propanol, Carbomer, Glycerin, Water.

Drug Facts Panel - Question and reporting of adverse events

OTC - QUESTIONS SECTION

Questions or reporting of adverse events?
Contact weekdays from 9AM to 5PM at 1-786-272-5677

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

60 ml NDC 78904-001-01

Label 60 mlLabel 60 ml

200 ml NDC 78904-001-02

200 ml Label200 ml Label

400 ml NDC 78904-001-03

Label 400 mlLabel 400 ml

500 ml NDC 78904-001-04

Label 500 mlLabel 500 ml

1000 ml NDC 78904-001-05

Label 1000 mlLabel 1000 ml

5000 ml NDC 78904-001-06

Label 5000 mlLabel 5000 ml

5 ml NDC 78904-001-07

Level 1

Label 5 mlLabel 5 ml

50x5 ml NDC 78904-001-07

Level 2

Label 50x5 mlLabel 50x5 ml

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
581662ethanol 70 % Topical GelPSN2
581662ethanol 0.7 ML/ML Topical GelSCD2
581662ethanol 70 % Topical GelSY2
581662ethyl alcohol 70 % Topical GelSY2

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78904-001-01Fashion Antiseptic Gel Hand Sanitizer60 mL in 1 BOTTLEGEL602
78904-001-02Fashion Antiseptic Gel Hand Sanitizer200 mL in 1 BOTTLEGEL2002
78904-001-03Fashion Antiseptic Gel Hand Sanitizer400 mL in 1 BOTTLEGEL4002
78904-001-04Fashion Antiseptic Gel Hand Sanitizer500 mL in 1 BOTTLEGEL5002
78904-001-05Fashion Antiseptic Gel Hand Sanitizer1000 mL in 1 BOTTLEGEL10002
78904-001-06Fashion Antiseptic Gel Hand Sanitizer5000 mL in 1 JUGGEL50002
78904-001-07Fashion Antiseptic Gel Hand Sanitizer50 in 1 CARTONGEL502
78904-001-07Fashion Antiseptic Gel Hand Sanitizer5 mL in 1 POUCHGEL52

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78904-001FASHION ANTISEPTIC GEL HAND SANITIZER (ETHYL ALCOHOL) GEL [JOAO HENRIQUE SILVA BESSA E CIA LTDA]2Legacy NDC, 8 package rows20201229_aa552a69-068a-44e4-e053-2a95a90a3631.zip

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
78904-00178904-001-01, 78904-001-02, 78904-001-03, 78904-001-04, 78904-001-05, 78904-001-06, 78904-001-07

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
b78630a7-5b64-f3fc-e053-2995a90a647baa552a69-068a-44e4-e053-2a95a90a36312020-12-28WarningsExact identifier
spl id: b78630a7-5b64-f3fc-e053-2995a90a647b
spl set id: aa552a69-068a-44e4-e053-2a95a90a3631

Reported adverse events (FAERS/openFDA)#

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