Active Ingredient(S)
Ethyl Alcohol 75% v/v. Purpose: Antimicrobial
Hand Sanitizer
FDA Label NDC 77607-100
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Xiamen Afgamarine Biotechnology Co., Ltd. for the product Hand Sanitizer (NDC 77607-100). 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 active ingredient(s), purpose, use, warnings, do not use, otc - when using, otc - stop use, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Antimicrobial.
Use
Recommended uses:
External use to help reduce bacteria on the skin.
Warnings
Cautions and Warning:
DANGER! Flammable warning. Keep away from open flame and sources of heat.
For external use only.
Do Not Use
Contraindications:
Do not use on children/infants less than 2 years of age (unless directed by a doctor/physician/health care practitioner/health care provider/health care profession).
Otc - When Using
When using this product avoid contact with eyes.
Otc - Stop Use
Stop use and ask/consult a doctor/physician/health care practitioner/health care provider/health care profession if irritation develops and lasts.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, call a poison control center or get medical help right away.
Directions
Superise children when they use this product. For occasional and personal dosmetic use. Rub thoroughly into hands for at least 30 seconds. Allow to dry.
Other Information
Security Package: Security feature is self-evident.
Waste disposal: The disposal of this product and container shall be in accordance with local/national regulations.
Inactive Ingredients
Aqua, Glycerin, Carbomer, Parfum, Triethanolamine.
Package Label - Principal Display Panel
Label (Label)
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