DISINFECT Wet WIPES by Jiangsu Xiaolikang Medical Technology Co., Ltd. DISINFECT Wet WIPES

DISINFECT Wet WIPES by

Drug Labeling and Warnings

DISINFECT 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]

DISINFECT WET WIPES- benzalkonium chloride cloth 
Jiangsu Xiaolikang Medical Technology Co., 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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DISINFECT Wet WIPES

DISINFECT Wet WIPES

Active Ingredient(s)

BENZALKONIUM CHLORIDE 1.3mg/pcs. Purpose: Antiseptic

Purpose

Antiseptic, DISINFECT Wet WIPES

Use

DISINFECT Wet WIPES 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 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 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.

Directions

• Wipe the surface of the skin and let it dry naturally.
• Supervise children under 6 years of age when using this product to avoid swallowing.

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
LEMON

Package Label - Principal Display Panel

DISINFECT WET WIPES 
benzalkonium chloride cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 80337-501
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

Inactive Ingredients
Ingredient Name	Strength
DIMETHICONE (UNII: 92RU3N3Y1O)
GLYCERIN (UNII: PDC6A3C0OX)
DIDECYLDIMONIUM CHLORIDE (UNII: JXN40O9Y9B)
WATER (UNII: 059QF0KO0R)
TOCOPHEROL (UNII: R0ZB2556P8)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
LEMON (UNII: 24RS0A988O)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80337-501-01	100 in 1 CANISTER; Type 0: Not a Combination Product	11/05/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	11/05/2020	11/13/2020

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

Establishment
Name	Address	ID/FEI	Business Operations
Jiangsu Xiaolikang Medical Technology Co., Ltd.		554546867	manufacture(80337-501)

Revised: 11/2020

Document Id: b430e10a-7128-e689-e053-2995a90a252e

34390-5

Set id: b35af9d0-7904-2c16-e053-2995a90a34bf

Version: 3

Effective Time: 20201115

 

Jiangsu