Other
Drug Facts
MANILDRA GROUP
100% AUSTRALIAN OWNED
Made in Australia
Distributed by: Manildra Milling Corporation
4501 College Blvd, Suite 310, Leawood, KS 66211
manildra.com.au • 1-800-323-8435
Manildra Stay Safe
FDA Label NDC 79268-001
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Manildra Milling Coporation for the product Manildra Stay Safe (NDC 79268-001). 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 other, otc - active ingredient, otc - purpose, indications & usage, warnings, otc - do not use, otc - when using, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Active Ingredient
Active ingredient
Alcohol 80% v/v
Otc - Purpose
Purpose
Antiseptic
Indications & Usage
Uses
- hand sanitizer to help reduce bacteria that potentially can cause disease
- for use when soap and water are not available
Warnings
Warnings
For external use only.
Flammable. Keep away from heat or flame.
Otc - Do Not Use
Do not use
- in children less than 2 months of age
- on open skin wounds
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 use 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 immediately.
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
Inactive Ingredient
Inactive ingredients
glycerin, hydrogen peroxide, purified water USP
Package Label.Principal Display Panel
stay safe™
MANILDRA STAY SAFE™
ALCOHOL ANTISEPTIC 80%
TOPICAL SOLUTION HAND SANITIZER.
Non-Sterile Solution
FLAMMABLE LIQUID
5L (1.3 Gal)
* Please review the disclaimer below.
