OTC Medication Information: Hand Wipes

HAND WIPES- benzalkonium chloride swab
Advanced Ultrasound Solutions Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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
(click image for full-size original)

NDC: 77677-013-01

SONO

HAND SANITIZING WIPES

Aloe and Bergamont Essental Oils

MADE IN USA

with globally sourced materials

One Large 7”x 8″ Wipes

Kills 99.9% of Germs

SONO
(click image for full-size original)
HAND WIPES
benzalkonium chloride swab
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:77677-013
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BENZALKONIUM CHLORIDE (BENZALKONIUM) BENZALKONIUM CHLORIDE 0.13 g in 100 g
Inactive Ingredients
Ingredient Name Strength
WATER
PHENOXYETHANOL
DECYL GLUCOSIDE
POTASSIUM SORBATE
SODIUM BENZOATE
EDETATE DISODIUM ANHYDROUS
CITRIC ACID MONOHYDRATE
ALOE VERA LEAF
.ALPHA.-TOCOPHEROL ACETATE
BERGAMOT OIL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:77677-013-20 20 PACKET in 1 PACKAGE contains a PACKET
1 0.13 g in 1 PACKET This package is contained within the PACKAGE (77677-013-20)
2 NDC:77677-013-01 1 PACKET in 1 PACKET contains a PACKET
2 0.13 g in 1 PACKET This package is contained within the PACKET (77677-013-01)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333A 05/15/2020
Labeler — Advanced Ultrasound Solutions Inc. (079552984)

Revised: 05/2023 Advanced Ultrasound Solutions Inc.

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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