Active Ingredient(S)
Alcohol 75% v/v. Purpose: Antiseptic
Hand Sanitizer
FDA Label NDC 79060-002
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Vara Home Usa Llc for the product Hand Sanitizer (NDC 79060-002). 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, when using this product, stop use and ask medical doctor, 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
Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.
Warnings
Flammable. Keep away from heat or flame.
For external use only.
Do Not Use
- in children less than 2 months of age
- on open skin wounds
When Using This Product
do not use in or near the eyes.
Stop Use And Ask Medical Doctor
if irritation or rash appears and lasts.
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 in your palm to thoroughly spread on both hands and rub into the skin until dry.
- Children under 6 years of age should be supervised when using this product.
Other Information
- Store below 106F (41F).
- May discolor certain fabrics or surfaces.
Inactive Ingredients
Water, Glycerin, Triethanolamine, Carbomer
Package Label - Principal Display Panel
30 mL NDC: 79060-002-01
Pdp (01)
60 mL NDC:79060-002-02
Pdp (02)
1000 mL NDC: 79060-002-03
Pdp (03)
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