LIFECARE ANTIBACTERIAL HAND WIPES- benzalkonium chloride cloth
Danthan Military NJ 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.

----------

Lifecare Antibacterial Hand Wipes

Product facts

Active ingredient

Benzalkonium Chloride 0.13%

Purpose

Antimicrobial

Use

personal hand hygiene

Warnings

For external use only.

Do not use

in the eyes.

Stop use and ask a doctor if

irritation and redness develop
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

Tear the package and use

Other Information

Store between 59-86°F (15-30°C)
Avoid freezing and excessive heat above 104°F (40°C)

Inactive ingredients

WATER, GLYCERIN, PHENOXYETHANOL, POLYAMINOPROPYL BIGUANIDE, POLYSORBATE 20, COCO NUCIFERA OIL.

Package Labeling:

Label

LIFECARE ANTIBACTERIAL HAND WIPES
benzalkonium chloride cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:80044-011
Route of Administration	TOPICAL

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

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYAMINOPROPYL BIGUANIDE (UNII: DT9D8Z79ET)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
COCOS NUCIFERA WHOLE (UNII: 245J88W96L)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:80044-011-01	1 in 1 PATCH	11/16/2020
1		5 mL in 1 PATCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	11/16/2020

Labeler - Danthan Military NJ Inc. (117589050)