Cleanze Hand Sanitizing wipes by Baoding Yusen Sanitary Health Supplies Co.,Ltd

Cleanze Hand Sanitizing wipes by

Drug Labeling and Warnings

Cleanze Hand Sanitizing wipes by is a Otc medication manufactured, distributed, or labeled by Baoding Yusen Sanitary Health Supplies Co.,Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

CLEANZE HAND SANITIZING WIPES- benzalkonium chloride cloth 
Baoding Yusen Sanitary Health Supplies 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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Drug Facts

Active Ingredient(s)

Benzalkonium chloride(0.3%)

Purpose

Antibacterial

Use

Use For hand sanitizing to decrease bacterial on the skin.

Recommended for repeated use.

Warnings

For external use only. Do not use if you are allergic to any of the ingredients.

Keep out of reach of children.

Directions

Adults and children 2 yrs and over, apply to hands and allow skin to dry without wiping.

Children under 2, ask doctor before use.

Inactive ingredients

Water,Aloe barbadensis leaf juice,PEG-75 Lanolin,Quaternium-52,PEG-8 Dimethicone,Disodium Cocoamphodiacetate,Disodium EDTA,Chamomilla Recutita(Matricaria) Flower Extract,Potassium Sorbate,Phenoxyethanol,Cetylpyridinium Chloride,Sodium Benzoate,Citric Acid

Package Label - Principal Display Panel

NDC: 78508-002-01

NDC: 78508-002-02

CLEANZE HAND SANITIZING WIPES 
benzalkonium chloride cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 78508-002
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
PEG-75 LANOLIN (UNII: 09179OX7TB)
WATER (UNII: 059QF0KO0R)
QUATERNIUM-52 (UNII: 588EQF3H1P)
PEG-8 DIMETHICONE (UNII: GIA7T764OD)
SODIUM BENZOATE (UNII: OJ245FE5EU)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
DISODIUM COCOAMPHODIACETATE (UNII: 18L9G3U51M)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
CETYLPYRIDINIUM CHLORIDE ANHYDROUS (UNII: 6BR7T22E2S)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
CHAMOMILE (UNII: FGL3685T2X)
PHENOXYETHANOL (UNII: HIE492ZZ3T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 78508-002-01	121.5 g in 1 BAG; Type 0: Not a Combination Product	06/02/2020	01/07/2021
2	NDC: 78508-002-02	2.285415 g in 1 BAG; Type 0: Not a Combination Product	08/11/2020	01/07/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	06/02/2020	01/07/2021

Labeler - Baoding Yusen Sanitary Health Supplies Co.,Ltd (530919462)

Registrant - Baoding Yusen Sanitary Health Supplies Co.,Ltd (530919462)

Establishment
Name	Address	ID/FEI	Business Operations
Baoding Yusen Sanitary Health Supplies Co.,Ltd		530919462	manufacture(78508-002)

Revised: 1/2021

Document Id: b8461f37-76b6-5b00-e053-2a95a90af7d5

34390-5

Set id: a7108416-04ef-25fe-e053-2995a90a1358

Version: 3

Effective Time: 20210106

 

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