Active Ingredient(S)
Alcohol 68% v/v. Purpose: Antiseptic
Hand Sanitizer Spray
FDA Label NDC 70983-025
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Saje Natural Business Inc. for the product Hand Sanitizer (NDC 70983-025). 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, product identity, use, 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
Purpose
Antiseptic, Hand Sanitizer
Product Identity
Hand Sanitizer - Antibacterial Spray
3.4 fl oz | 100 ml
6.8 fl oz | 200 ml
Use
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
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. If contact occurs with eyes, rinse thoroughly with water.
Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.
Keep out of reach of children. If swallowed, contact a Poison Control Center right away or get medical help right away.
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
- Spray 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.
Other Information
- Store between 15-30C (59-86F)
- Avoid freezing and excessive heat above 40C (104F)
Inactive Ingredients
purified water, aloe barbadensis leaf juice powder, glycerin.
Hand Sanitizer Spray - Package Label
100 mL NDC: 70983-025-01
200 mL NDC: 70983-025-02
* Please review the disclaimer below.
