MAINCLEAN DISINFECTANT WIPES 11060208- disinfection wet wipes patch 
Shandong Mainclean Medical 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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MainClean, Disinfectant Wipes, *60

Active ingredient

Alcohol, 15% v/v, antiseptic

Inactive ingredient

Cetylpyridinium Chloride

Propylene Glycol

Phenoxyethanol

Glycerin

Ethylhexylglycerin

Water

Purpose

This product is used to wipe hands, faces, skins, etc. It can also be used to clean many kinds of places.

When using

This product is used to wipe hands, faces, skins, etc. It can also be used to clean many kinds of places.

Do not use

Use only as directed.
Do not use for cases not directed.

Stop use

Stop use if the product's volatile gases cause discomfort, or if you experience respiratory irritation such as cough, asthma, or difficulty breathing.

Keep out of reach of children

Keep out of reach of children.

Indications & usage

This product is used to wipe hands, faces, skins, etc. It can also be used to clean many kinds of places.

Dosage & administration

Use it as needed, after following the usage instructions.

For external use only.

Warnings

Do not apply this product to red and swollen skin, wound or any part sensitive to it.
Keep this product out of children’s reach in case they might eat it.
Do not throw this product into the toilet as it cannot dissolve.

Package label. Principal display panel

2011

MAINCLEAN DISINFECTANT WIPES 11060208 
disinfection wet wipes patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75162-2011
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL15   in 100 
Inactive Ingredients
Ingredient NameStrength
PROPYLENE GLYCOL (UNII: 6DC9Q167V3) 0.25 
WATER (UNII: 059QF0KO0R) 84.585 
CETYLPYRIDINIUM CHLORIDE ANHYDROUS (UNII: 6BR7T22E2S) 0.075 
PHENOXYETHANOL (UNII: HIE492ZZ3T) 0.05 
GLYCERIN (UNII: PDC6A3C0OX) 0.025 
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) 0.015 
Product Characteristics
Color    Score    
ShapeFREEFORMSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:75162-2011-160 in 1 PACKAGE; Type 0: Not a Combination Product04/20/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A04/20/2020
Labeler - Shandong Mainclean Medical Products Co., Ltd. (418445935)
Registrant - A03 Lab of BTS (548009541)
Establishment
NameAddressID/FEIBusiness Operations
Shandong Mainclean Medical Products Co., Ltd.418445935label(75162-2011) , manufacture(75162-2011)

Revised: 4/2020
Document Id: a3aae0f0-add9-4381-e053-2a95a90a50a5
Set id: a3aae0f0-add8-4381-e053-2a95a90a50a5
Version: 1
Effective Time: 20200420
 
Shandong Mainclean Medical Products Co., Ltd.