Keep Clean Surface Cleaning Wipes by Zhejiang Ruolin Hygienic Products Co., Ltd. Antibacterial Wipes

Keep Clean Surface Cleaning Wipes by

Drug Labeling and Warnings

Keep Clean Surface Cleaning Wipes by is a Otc medication manufactured, distributed, or labeled by Zhejiang Ruolin Hygienic Products Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

KEEP CLEAN SURFACE CLEANING WIPES- benzalkonium chloride and didecyldimonium chloride 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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Antibacterial Wipes

Active Ingredient

Benzalkonium Chloride 0.1%

Didecyldimonium Chloride 0.2%

Purpose

Antimicrobial

USE

Wipes for surface

Warning

• For use on surfaces and to sanitize skin
• Gentle on skin - contains aloe
• No rinsing or wiping required
• Nor should you use them on or near your eyes. if you gen any of the ingredients in your eye, remove any contacts and gently rinse the eye with water for as long as needed.
• If ingested or if irritation persists, contact a poison control cnter for advice or seek medical attention.
• these are wipes, not toilet paper......，please don't flush them down toilets. Before using on unsealed surfaces or fabric, we recommend testing a small area for discoloration first. Don't store or use these near heat sources or an open flame.

Storage:

Refrigerate after opening (just kidding), Just store these at room temperature. wali-in freezers, boiler rooms and things of that nature don't count. just store them at regular "tank top to sweatshirt" room temperature. Tjis container is not designed for refiils, please do not reuse it for wipes. Also please recycle this container if possible. It's really not that hard.

Children under 6 should be supervised when using wipes.

Directions

• Apply wipe to surface and allow to dry
• Children under 6 years of age should be supervised when using this product.

Inactive ingredients

Water, Glycerin, Ehtylhexylglycerin, Phenoxyethanol, Propylene Glycol

KEEP CLEAN SURFACE CLEANING WIPES 
benzalkonium chloride and didecyldimonium chloride swab

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 78823-012
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.10 g  in 100 g
didecyldimonium chloride (UNII: JXN40O9Y9B) (DIDECYLDIMONIUM - UNII:Z7F472XQPA)	didecyldimonium chloride	0.20 g  in 100 g

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 78823-012-01	70 in 1 CANISTER	06/23/2020	06/24/2020
1		3.78 g in 1 POUCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	06/23/2020	06/24/2020

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

Establishment
Name	Address	ID/FEI	Business Operations
Zhejiang Ruolin Hygienic Products Co., Ltd.		415426870	manufacture(78823-012)

Revised: 6/2020

Document Id: 939d7b88-a60f-438b-a315-289e505c0015

34390-5

Set id: daf869cf-6e5d-4d27-9de3-944b75178997

Version: 10

Effective Time: 20200624

 

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