Homworks Antibacterial Hand Wipes by Acadian Crossing Consumer Products, LLC. / Organic Filling Solutions, LLC

Homworks Antibacterial Hand Wipes by

Drug Labeling and Warnings

Homworks Antibacterial Hand Wipes by is a Otc medication manufactured, distributed, or labeled by Acadian Crossing Consumer Products, LLC., Organic Filling Solutions, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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.

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Drug Facts

Active Ingredient

Benzalkonium Chloride 0.14% w/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

HOMWORKS ANTIBACTERIAL HAND WIPES 
benzalkonium chloride cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82131-295
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.14 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
COCAMIDOPROPYL DIMETHYLAMINE (UNII: L36BM7DG2T)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
GLYCERIN (UNII: PDC6A3C0OX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82131-295-80	80 mL in 1 CANISTER; Type 0: Not a Combination Product	11/01/2021	11/01/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	11/01/2021	11/01/2023

Labeler - Acadian Crossing Consumer Products, LLC. (830941121)

Registrant - Acadian Crossing Consumer Products, LLC. (830941121)

Establishment
Name	Address	ID/FEI	Business Operations
Organic Filling Solutions, LLC		080759841	manufacture(82131-295)

Revised: 7/2023

Document Id: 00261ccc-893c-ed9b-e063-6294a90a23b6

34390-5

Set id: c80ca04c-dc9a-cf5c-e053-2995a90a0311

Version: 5

Effective Time: 20230710