Active Ingredient(S)
Ethyl Alcohol 70% v/v. Purpose: Antiseptic
Hand Sanitizer
FDA Label NDC 78389-003
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Absolute Marketing, Inc. for the product Hand Sanitizer (NDC 78389-003). 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 - when using, otc - stop use, otc - keep out of reach of children, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Antiseptic
Use
Hand Sanitizer to reduce bacterial organisms on the skin.
Warnings
For external use only. Flammable. Keep away from heat or flame
Otc - When Using
Avoid contact with eyes. If contact occurs, flush eyes throughly with water.
Stop use and ask a doctor if irritation or rash develops and persists. T
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.
Otc - Stop Use
Stop use and ask a doctor if irritation or rash develops and persists.
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
- Dispense a small amount onto palm of hand and rub briskly and thoroughly over surfaces of both hands until dry.
- Children under 6 years of age should be supervised while using this product.
Other Information
- Store below 110 °F (43 °C)
- May discolor certain fabrics or surfaces.
Inactive Ingredients
Water, Glycerin, Acrylates/c10-30 Alkyl Acrylate Crosspolymer, Triethanolamine
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