Purpose
Antiseptic, Hand Sanitizer
Emu Hand Sanitizer Mist Mint
FDA Label NDC 80464-1004
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Everyone Must Use, Llc for the product Emu Hand Sanitizer Mist Mint (NDC 80464-1004). 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, drug facts, otc - active ingredient, uses, warnings, 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
Drug Facts
This is a hand sanitizer manufactured according to the Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (CoViD-19); Guidance for Industry.
The hand sanitizer is manufactured using only the following United States Pharmacopoeia (USP) grade ingredients in the preparation of the product (percentage in final product formulation) consistent with World Health Organization (WHO) recommendations:
- Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (80%, volume/volume (v/v)) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
- Glycerol (1.45% v/v).
- Hydrogen peroxide (0.125% v/v).
- Sterile distilled water or boiled cold water.
The firm does not add other active or inactive ingredients. Different or additional ingredients may impact the quality and potency of the product.
Otc - Active Ingredient
| Active Ingredient | Purpose |
| Ethyl Alcohol 62% | Antiseptic |
Uses
Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.
Warnings
For external use only. | Flammable. | Keep away from heat or flame. | Contents under pressure.
Do Not Use
on children less than 2 months of age. Do not use 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 right away.
Directions
Place enough product on hands to cover all surfaces. Rub hands together until dry. Supervise childrenunder 6 years of age to avoid swallowing.
Other Information
Store between 15°-30° C (59°-86°F)
Inactive Ingredients
Aloe Barbadensis Leaf Juice, Fragrance, Glycerin, Purified Water, Tocopheryl Acetate
Questions Or Comments?
1-800-250-4643
Package Label - Principal Display Panel
Net Wt 2.2 FL OZ (62.4g) NDC: 80464-1004-1
Label (Mint)
* Please review the disclaimer below.
