Active Ingredient(S)
Alcohol 70% v/v. Purpose: Antimicrobial
Hand Sanitizer
FDA Label NDC 78831-701
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Mr Knox Llp. for the product Hand Sanitizer (NDC 78831-701). 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
Antimicrobial, Hand Sanitizer
Use
For handwashing to decrease bacteria on the skin.
Recommended for repeated use.
Warnings
For external use only. Flammable. Keep away from fire or flame
Otc - When Using
When using this product keep away from eyes. In case of eye contact, rinse eyes with water.
Stop use and ask a doctor if redness and irritation develops. If issues persist, seek medical attention.
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 redness and irritation develops. If issues persist, seek medical attention.
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 cover your hands.
- Rub hands together briskly until dry.
- Children under 6 years of age should be supervised when using this product.
Other Information
- Protect the product in this container from excessive hear and direct sun.
- Store below 104F (40C).
- May discolor certain fabrics.
Inactive Ingredients
Aqua (Water, Eau), Citrus Aurantium Dulcis (Orange) Peel Oil, Citrus Limon (Lemon) Peel Oil, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aminomethyl Propanol
Package Label - Principal Display Panel
100 mL NDC: 78831-701-01
Hand Sanitizer Gel 100ml (Mk Handsanitizer 100ml)
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