Active Ingredient(S)
Alcohol 70% v/v. Purpose: Antimicrobial
Instant Hand Sanitizer
FDA Label NDC 78766-001
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Zhejiang Bayside Biotech Co., Ltd. for the product Instant Hand Sanitizer (NDC 78766-001). 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 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, Hand Sanitizer
Use
Hand Sanitizer to help reduce bacteria on the skin.
Warnings
- For external use only. Keep out of reach of children.
- Flammable. Keep away from source of heat or fire.
Do Not Use
- in children less than 2 months of age
- on open skin wounds
Otc - When Using
When using this product avoid contact with eyes. If contact occurs in case, rinse with water.
Otc - Stop Use
Stop using this product and ask doctor if irritation or redness develops and lasts.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
Directions
- Wet hands thoroughly and rub together until dry.
- Children under 6 years of age should be supervised when using instant hand sanitizer.
Other Information
- Seal and store at a temperature below 40C (104F)
Inactive Ingredients
glycerin, water, Isopropyl Myristate, Carbomer, Aloe Leaf juice, Tocopheryl Acetate, Aminomethyl propanol, Rose oil.
Package Label - Principal Display Panel
266 mL NDC: 78766-001-01
Image Description (Drug 01)
Image Description (Drug 01)
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