DISINFECTING WET WIPES- benzalkonium chloride cloth

DISINFECTING WET WIPES by

Drug Labeling and Warnings

DISINFECTING WET WIPES by is a Otc medication manufactured, distributed, or labeled by Jiangsu Xiaolikang Medical Technology Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

DISINFECTING WET WIPES

Active Ingredient(s)

BENZALKONIUM CHLORIDE 0.1%

Purpose

Antiseptic

Use

To help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Warnings

For external use only.

Do not use

• in children less than 2 months of age
• on open skin wounds

WHEN USING

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.
Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

STOP USE

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• Wipe the surface of the skin

Other information

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

Inactive ingredients

WATER
DIDECYLDIMONIUM CHLORIDE
PHENOXYETHANOL
CETYLPYRIDINIUM CHLORIDE
ALOE VERA LEAF
TOCOPHEROL
GLYCERIN
DIMETHICONE

Package Label - Principal Display Panel

INGREDIENTS AND APPEARANCE

DISINFECTING WET WIPES 
benzalkonium chloride cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 80337-801
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.13 mg  in 100 mg

Inactive Ingredients
Ingredient Name	Strength
DIMETHICONE (UNII: 92RU3N3Y1O)
WATER (UNII: 059QF0KO0R)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
TOCOPHEROL (UNII: R0ZB2556P8)
GLYCERIN (UNII: PDC6A3C0OX)
DIDECYLDIMONIUM CHLORIDE (UNII: JXN40O9Y9B)
CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80337-801-01	50 mg in 1 BAG; Type 0: Not a Combination Product	03/09/2021
2	NDC: 80337-801-02	100 mg in 1 CANISTER; Type 0: Not a Combination Product	03/09/2021
3	NDC: 80337-801-03	800 mg in 1 CYLINDER; Type 0: Not a Combination Product	03/09/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M003	03/09/2021

Labeler - Jiangsu Xiaolikang Medical Technology Co., Ltd. (554546867)

Establishment
Name	Address	ID/FEI	Business Operations
Jiangsu Xiaolikang Medical Technology Co., Ltd.		554546867	manufacture(80337-801)