Purpose
Antispetic Skin Cleanser
Oz Naturals Antiseptic Gel Handsanitizer
FDA Label NDC 75592-201
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Oz Naturals Llc for the product Oz Naturals Antiseptic Gel Handsanitizer (NDC 75592-201). 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 purpose, use, directions for use:, active ingredient, warnings:, warnings, inactive ingredients:, distributed by oznaturals®, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Use
Antiseptic skin cleanser to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.
Directions For Use:
Adults and children over 2 years
Supervise children when they use this product
For occasional and personal domestic use
Rub thoroughly into hands for at least 30 seconds. Allow to dry.
Active Ingredient
Ethyl Alcohol 70%p/p
Warnings:
For external use only
• When using this product, avoid contact with eyes. If contact occurs, rinse thoroughly with water
• Stop use and consult a health care professional if irritation develops
• Keep out of reach of children
• If swallowed, call a poison control center or get medical help right away
• Flammable
• Keep away from flames or heat source
• Avoid temperature over 43°C (110°F)
Warnings
Keep out of reach of children
Inactive Ingredients:
Aqua/Water/Eau, Glycerin, Tocopheryl Acetate, Aloe Barbadensis Leaf Juice, Citrus Paradisi (Grapefruit) Peel Oil, Carbomer, Triethanolamine
Distributed By Oznaturals®
319 Clematis St. Ste. 700,
West Palm Beach, FL 33401
MADE IN CANADA
Principal Display Panel
OZNATURALS Antiseptic Gel Hand Sanitizer
KILLS HARMFUL BACTERIA AND GERMS
1 Oz Sanitizer Label (1oz Sanitizer Label)
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