Hand Wipes Swab
FDA Label NDC 77677-013

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Advanced Ultrasound Solutions Inc. for the product Hand Wipes (NDC 77677-013). 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, purpose, uses, warnings, when using this product, stop use and ask a doctor, 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

Active Ingredient

Benzalkonium chloride.........0.13%

Purpose

Antimicrobial

Uses

  • For hand sanitizing to decrease bacteria on the skin
  • Recommended for repeated use

Warnings

For external use only

​Do not use if you are allergic to any of these ingredients

When Using This Product

Avoid contact with eyes. In case of eye contact, flush eyes with water.

Stop Use And Ask A Doctor

If irritation or redness develops, or if condition persists for more than 72 hours.

Keep Out Of Reach Of Children

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • adults and childrens 2 years and over: apply to hands, allow to dry without wiping
  • children under 2 years: ask a doctor before use

    • To Dispense: ​Peel back front label slowly. Remove Wipes

    To Reseal: ​Firmly rub thumb over label. Dispose of wipe in thrash. Do not flush

Other Information

  • Store below 95°F (35°C)
  • keep closed tightly
  • may discolor certain fabrics or surfaces

Inactive Ingredients

Purified Water, Phenoxyethanol, Decyl Glucoside, Potassium Sorbate, Sodium Benzoate, Disodium EDTA, Citric Acid, Aloe Barbadensis (Aloe) Leaf Extract, Tocopheryl Acetate, Organic Citrus Auranium Bergamia Fruit Oil.

Principal Display Panel

NDC: 77677-013-20

SONO®​ HEALTHCARE

MADE IN USA

HAND SANITIZING WIPES

WITH MOISTURIZER AND BERGAMOT ESSENTIAL OIL

Kills 99.9% of most common germs

20 Wipes

New Contents: 20 pre-moistened sanitizing wipes, 7X8

Label (20)

Label (20)

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