Otc - Active Ingredient
Active ingredient[s]
Alcohol 80% v/v
Alcohol Antiseptic 80% Topical Solution Hand Sanitizer Non-sterile Solution
FDA Label NDC 64521-5678
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Sarkli-repechage, Ltd. for the product Alcohol Antiseptic 80% Topical Solution Hand Sanitizer Non-sterile Solution (NDC 64521-5678). 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 otc - active ingredient, otc - purpose, indications & usage, warnings, otc - when using, otc - stop use, otc - keep out of reach of children, dosage & administration, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Purpose
Antiseptic
Indications & Usage
Use[s]
Hand Sanitizer to help reduce bacteria that potentially can cause disease.
For use when soap and water are not available.
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.
Warnings
Warnings
For external use only. Flammable. Keep away from heat or flame.
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 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.
Dosage & 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.
Instructions For Use
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 15–30C (59–86F)
• Avoid freezing and excessive heat above 40C (104F)
Inactive Ingredient
Inactive ingredients glycerin, hydrogen peroxide, purfied water USP
Otc - Questions
Questions or comments?
Call Toll-Free 1-800-SKIN (1-800-248-7546) Monday-Friday 9am-5:30pm ET
Repechage Alcohol Antiseptic 80% Topical Solution Hand Sanitizer Non-Sterile Solution
118 mL, NDC 64521-5678-4
Repechage Alcohol Antiseptic 80% Topical Solution Hand Sanitizer Non-sterile Solution (Handsanitizeralcohol4oz)
59 mL, NDC 64521-5678-2
59 mL Label (Handsanitizeralcohol2oz)
* Please review the disclaimer below.
