Disinfecting Wipes by Tianjin Zejun Int'l Trade Co., Ltd / Cangzhou Juyuan Sanitary Prducts Co., Ltd

Disinfecting Wipes by

Drug Labeling and Warnings

Disinfecting Wipes by is a Otc medication manufactured, distributed, or labeled by Tianjin Zejun Int'l Trade Co., Ltd, Cangzhou Juyuan Sanitary Prducts Co., Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DISINFECTING WIPES- hand sanitizer cloth 
Tianjin Zejun Int'l Trade 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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Active Ingredient(s)

Benzalkonium Chloride 0.45% w/w. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

Use

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

Warnings

For external use only. Flammable. Avoid exposure to the sun.

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

• Place enough product on hands to cover all surfaces. Rub hands together until dry.
• 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

aloe, citric acid, glycerin, propylene glycol, purified water USP.

Package Label - Principal Display Panel

80 Wipes in 1 Pail NDC: 79621-528-01

DISINFECTING WIPES 
hand sanitizer cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 79621-528
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.45 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
ALOE (UNII: V5VD430YW9)	0.05 g  in 100 g
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)	0.01 g  in 100 g
GLYCERIN (UNII: PDC6A3C0OX)	0.5 g  in 100 g
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)	0.3 g  in 100 g
WATER (UNII: 059QF0KO0R)	98.69 g  in 100 g

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 79621-528-01	500 g in 1 PAIL; Type 0: Not a Combination Product	07/17/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	07/17/2020	09/06/2020

Labeler - Tianjin Zejun Int'l Trade Co., Ltd (543257783)

Registrant - Tianjin Zejun Int'l Trade Co., Ltd (543257783)

Establishment
Name	Address	ID/FEI	Business Operations
Cangzhou Juyuan Sanitary Prducts Co., Ltd		526891925	manufacture(79621-528)

Revised: 12/2021

Document Id: d2fedd58-285e-7b86-e053-2995a90ad72b

34390-5

Set id: aa9e08f4-196f-22e9-e053-2995a90ad2a6

Version: 4

Effective Time: 20211212