Active Ingredient(S)
Ethyl Alcohol (Ethanol) 70%. Purpose: Antiseptic
Hand Sanitizer Gel
FDA Label NDC 43493-0000
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Avaria Health & Beauty Corp for the product Hand Sanitizer (NDC 43493-0000). 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, do not use, otc - when using, otc - stop use, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Antiseptic, Hand Sanitizer
Use
For personal hand hygiene to help prevent the spread of bacteria. Kills harmful bacteria and germs. Provides maximum hydration and prevents dryness.
Warnings
For external use only; avoid contact with eyes. If contact occurs, rinse thoroughly with water.
Do not use by mouth, in nostrils, on wounds or damaged skin, with tight bandages.
Flammability warning. Keep away from open flame and sources of heat.
Do Not Use
- by mouth
- in nostrils
- on wounds or damaged skin
- with tight bandages
Otc - When Using
Stop use and ask a doctor if irritation develops.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Otc - Stop Use
Stop use and ask a doctor if irritation develops.
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
- Adults and children 2 years and over:
- Rub thoroughly into hands for at least 30 seconds
- Allow to dry
- Supervise children when they use this product
- Children under 2 years: do not use
Other Information
- Store at room temperature; do not store above 40C / 100F
Inactive Ingredients
Aqua, Carbomer, Glycerin, Hyaluronic Acid, Triethanolamine
Package Label - Principal Display Panel
400 mL NDC: 43493-000-00
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