Active Ingredient(S)
Ethyl Alcohol 67%
Hand Sanitizer
FDA Label NDC 75778-006
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Audy Global Enterprises Inc. for the product Hand Sanitizer (NDC 75778-006). 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, otc - keep out of reach of children, otc - when using, otc - stop use, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Antiseptic
Use
For handwashing to decrease bacteria on the skin. Recommended for repeated use.
Warnings
For external use only. Flammable. Keep away from heat or flame.
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.
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 redness develop.
If condition persists for more than 72 hours.
Directions
- Place enough product in your palm to thoroughly cover your hands
- Children under 6 years of age should be supervised when using this product
- Rub hands together briskly until dry
Other Information
- Protect the product in this container
- Store below 104°F (40°C)
- May discolor certain fabrics.
from excessive heat and direct sun.
Inactive Ingredients
Water, Aloe Barbadensis Leaf Juice,
Radish Root Ferment Filtrate,
Fragrance (parfum), Glycereth-26,
Lime (Citrus Aurantifolia) Seed Oil,
Lemon (Citrus Limon) Peel Oil, FD&C
Red No. 40, FD&C Yellow No. 5,
Limonene, Citral, Citronellol, Linalool
Package Label - Principal Display Panel
38 mL NDC: 75778-006-01
45mL NDC: 75778-006-02
* Please review the disclaimer below.
