ANTIBACTERIAL WET- benzalkonium chloride liquid
Xi'an Livingbond Nonwoven Products Corp., Ltd.

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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Antibacterial Wet

Drug Facts

Active Ingredient

Benzalkonium Chloride 0.1%

Purpose

Antibacterial

Uses:

For hand washing to decrease bacteria on the skin. May be used on face, arms and legs.

Warnings:

For external use only.

Keep out of reach of children,

except with adult supervision. Keep out of eyes. In case of contact, rinse with water. If irritation or rash develops, discontinue use. Consult doctor if irritation persists for more than 72 hours. If swallowed, seek medical attention or contact a Poison Control Center.

Directions:

Tear open. Unfold the wipe. Clean hands or affected area and discard.

Inactive Ingredients:

Water, Glycerin, Lauryl Glucoside, DMDM, Hydantoin, Aloe Barbadensis Leaf Extract, Disodium EDTA, PEG 12, Dimethicone, Panthenol, Chamomila Recutita (Matricaria) Extract, Lodopropynyl Butlycarbamae, Tocopheryl Acetate (Vitamin E), Allantoin.

Package Labeling:

Label

ANTIBACTERIAL WET
benzalkonium chloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:50014-110
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.3 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
LAURYL GLUCOSIDE (UNII: 76LN7P7UCU)
HYDANTOIN (UNII: I6208298TA)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
POLYETHYLENE GLYCOL 12000 (UNII: VM53EE110J)
DIMETHICONE (UNII: 92RU3N3Y1O)
PANTHENOL (UNII: WV9CM0O67Z)
MATRICARIA CHAMOMILLA (UNII: G0R4UBI2ZZ)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
ALLANTOIN (UNII: 344S277G0Z)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:50014-110-01	1 in 1 BAG	11/27/2017	04/30/2021
1		0.1 g in 1 PATCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
2	NDC:50014-110-30	30 in 1 BAG	11/27/2017	04/30/2021
2		0.1 g in 1 PATCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
3	NDC:50014-110-50	50 in 1 CANISTER	11/27/2017	04/30/2021
3		0.1 g 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	11/27/2017	04/30/2021

Labeler - Xi'an Livingbond Nonwoven Products Corp., Ltd. (529686742)

Revised: 5/2021

Document Id: c2d9940a-ce7c-5fd0-e053-2a95a90a4bc8

Set id: 09f0d5f2-b3d5-4d78-9cc7-51eafdd3df64

Version: 4

Effective Time: 20210521

Xi'an Livingbond Nonwoven Products Corp., Ltd.