Drug Facts Panel - Active Ingredients
Denatured Ethyl Alcohol 70%. Purpose: Antiseptic
Fashion Antiseptic Gel Hand Sanitizer
FDA Label NDC 78904-001
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Joao Henrique Silva Bessa E Cia Ltda for the product Fashion Antiseptic Gel Hand Sanitizer (NDC 78904-001). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding drug facts panel - active ingredients, drug facts panel - purpose, drug facts panel - uses, drug facts panel - warnings, otc - do not use, otc - when using, otc - stop use, otc - ask doctor, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Drug Facts Panel - Purpose
Purpose: Antiseptic.
Drug Facts Panel - Uses
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
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
Do not use
● in children less than 2 months of age
● on open skin wounds
Otc - When Using
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
Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.
Otc - Ask Doctor
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
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Drug Facts Panel - Directions
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
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 ingredients:
Aminomethyl Propanol, Carbomer, Glycerin, Water.
Drug Facts Panel - Question And Reporting Of Adverse Events
Questions or reporting of adverse events?
Contact weekdays from 9AM to 5PM at 1-786-272-5677
Package Label - Principal Display Panel
60 ml NDC 78904-001-01
200 ml NDC 78904-001-02
400 ml NDC 78904-001-03
500 ml NDC 78904-001-04
1000 ml NDC 78904-001-05
5000 ml NDC 78904-001-06
5 ml NDC 78904-001-07
Level 1
50x5 ml NDC 78904-001-07
Level 2
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