OTC Medication Information: Homworks Antibacterial Hand Wipes

HOMWORKS ANTIBACTERIAL HAND WIPES- benzalkonium chloride cloth
Acadian Crossing Consumer Products, LLC.

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 0.14% v/v

Purpose

Antimicrobial Agent

Use

Use • Reduce bacteria that can potentially cause disease.

Warnings

For External Use only: hands, general cleansing.

Do not use • if you are allergic to any of the ingredients.

Does not replace wipes used for medical procedures.
When using this product

  • Do not get into eyes. If contact occurs, rinse thoroughly with water.
  • Avoid contact with broken skin.

Stop use and ask doctor if irritation, rash or redness develops and continues 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

Directions:

• Adults and children over 2 years old:

•Apply to hands
•Allow skin to dry without wiping

• Children under 2 years

•Ask doctor before use

• Single use wipes for hands. Close properly after dispensing to maintain purity.

Other Information

keep out of light; store at room temperature 59ºF – 86ºF.

Water, Cocamidopropyl Dimethylamine, Glycerin, Cocamidopropyl Betaine, Fragrance.

Wipe Dimensions: 6” x 7.75” (15.2 cm x 19.6 cm)
www.HOM-works.com
Distributed by Acadian Crossing Consumer Products, LLC., San Antonio, TX 78232

PDP Label
(click image for full-size original)

HOMWORKS ANTIBACTERIAL HAND WIPES
benzalkonium chloride cloth
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:82131-295
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BENZALKONIUM CHLORIDE (BENZALKONIUM) BENZALKONIUM CHLORIDE 0.14
Inactive Ingredients
Ingredient Name Strength
WATER
COCAMIDOPROPYL DIMETHYLAMINE
COCAMIDOPROPYL BETAINE
GLYCERIN
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:82131-295-80 80 CLOTH in 1 CANISTER None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333A 11/01/2021
Labeler — Acadian Crossing Consumer Products, LLC. (830941121)
Registrant — Acadian Crossing Consumer Products, LLC. (830941121)
Establishment
Name Address ID/FEI Operations
Organic Filling Solutions, LLC 080759841 manufacture (82131-295)

Revised: 07/2021 Acadian Crossing Consumer Products, LLC.

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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