KLEEN FREAK DISINFECTING WIPES- benzalkonium chloride and alcohol swab
Zhejiang Ruolin Hygienic Products 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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Wipes

Active Ingredient

Benzalkonium Chloride 0.1%

Alcohol 4%

Purpose

Antibacterial

USE

Hand sanitizer to help reduce bacteria on the skin.

Warning

For external use only.
When using this product, Do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water.

Stop use and ask a doctor, if irritaion and rash appears and lasts.

If swallowed, get medical help or contact a Poison Contrl Center right away.

Directions

Wipe surface with product and allow to dry
Discard wipes in trash receptacle after use. Do not flush.
Children under 6 years of age should be supervised when using this product.

Inactive ingredients

Water, Glycerin, Ehtylhexylglycerin, Didecyldimethylemmonium CHLORIDE, Phenoxyethanol, Alcohol, Propylene Glycol

label image

KLEEN FREAK DISINFECTING WIPES
benzalkonium chloride and alcohol swab

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:78823-037
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.10 g in 100 g
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	4 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
water (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
DIDECYLDIMONIUM CHLORIDE (UNII: JXN40O9Y9B)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:78823-037-01	70 in 1 CANISTER	08/28/2020
1		3.8 g in 1 POUCH; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	08/28/2020

Labeler - Zhejiang Ruolin Hygienic Products Co., Ltd. (415426870)

Name	Address	ID/FEI	Business Operations
Establishment
Zhejiang Ruolin Hygienic Products Co., Ltd.		415426870	manufacture(78823-037)