SOAPBOX ANTIBACTERIAL HAND WIPES- benzalkonium chloride cloth

Soapbox Antibacterial Hand Wipes by

Drug Labeling and Warnings

Soapbox Antibacterial Hand Wipes by is a Otc medication manufactured, distributed, or labeled by DYNAMIC WIPE INDUSTRIES LTD.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredient

Benzalkonium Chloride 0.13%

Purpose

Antiseptic

Use:

• Hand sanitizer to help reduce bacteria on the skin. For use when soap and water not available.

Warnings

For external use only

When using this product

• Avoid getting into the eyes.
• In case of eye contact immediately flush eyes thoroughly with water.

Stop use and ask a doctor if

• Irritation or redness develops
• Condition persist for more than 72 hours
• Redness is present

Keep out of reach of children.

In case of accidental ingestion, contact a doctor or Poison Control Center immediately.

Directions:

• Throughly wipe hands with cloth
• Rub hands together until dry
• No rinsing required

Other information

• Dispose of properly, do not flush.

Inactive Ingredients

Water, Polysorbate 20, Glycerin, Potassium Sorbate, Aloe (Aloe Barbadensis) Leaf Extract, Dehydroacetic Acid, Phenoxyethanol, Citric Acid

Package Labeling:20wipes

Package Labeling:50wipes

Package Labeling:400wipes

INGREDIENTS AND APPEARANCE

SOAPBOX ANTIBACTERIAL HAND WIPES 
benzalkonium chloride cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 77645-004
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	1.3 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
GLYCERIN (UNII: PDC6A3C0OX)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
DEHYDROACETIC ACID (UNII: 2KAG279R6R)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 77645-004-01	20 in 1 PACKAGE	10/15/2020
1		3 mL in 1 PATCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
2	NDC: 77645-004-02	50 in 1 PACKAGE	10/15/2020
2		3 mL in 1 PATCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
3	NDC: 77645-004-03	400 in 1 CANISTER	10/15/2020
3		3 mL in 1 PATCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	10/15/2020

Labeler - DYNAMIC WIPE INDUSTRIES LTD. (532208402)