Otc - Active Ingredient
Active ingredients
Alcohol 71% v/v
Hand Sanitizer
FDA Label NDC 47993-329
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Ingbo Jiangbei Ocean Star Trading Co.,ltd for the product Hand Sanitizer (NDC 47993-329). 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 - stop use, otc - keep out of reach of children, dosage & administration, other safety information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Antiseptic
Indications & Usage
Uses：
Hand sanitizer to help reduce germs on the skin that potentially can cause disease.
Warnings
Warnings:
Flammable. Keep away from fire or flame
For external use only.
Otc - Stop Use
Discontinue use and ask a doctor if
- Irritation and redness develop.
- Condition persists for more than 72 hours.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact a poison control center immediately.
Dosage & Administration
Directions:
- Spray on clean, dry hands and nails.
- Wet hands thoroughly with product.
- Rub hands together for no less than 15 seconds, paying particular attention to interdigital spaces, fingernails and cuticles.
- Allow to dry without wiping.
- Rub hands together briskly until dry.
Other Safety Information
Other information:
Store in a cool, dry place below 104℉ (40℃).
Inactive Ingredient
Inactive ingredients:
Water, Isopropyl Alcohol, Glycerin, Glyceryl Laurate.
Package Label.Principal Display Panel
Image Description (500ml)
Image Description (59ml)
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