ALCOHOL WET WIPES- wet wipes swab 
DISINFECTING WIPES- wet wipes swab 
ANTIBACTERIAL WET WIPES- wet wipes swab 
ALCOHOL WET TISSUE- wet tissue swab 
SHANDONG PROVINCE RUNHE SANITARY MATERIALS 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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Dosage

Active ingredient

Keep out of reach of children

Warning

Indications & Usage

Purpose

Antibacterial Wet Wipes

label

Tissue

disinfecting wipes

ALCOHOL WET WIPES 
wet wipes swab
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74439-002
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL30 g  in 100 g
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.624 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
DIDECYLDIMONIUM CHLORIDE (UNII: JXN40O9Y9B)  
WATER (UNII: 059QF0KO0R)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
DECYL GLUCOSIDE (UNII: Z17H97EA6Y)  
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:74439-002-0150 g in 1 PACKET; Type 0: Not a Combination Product04/13/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A04/13/2020
DISINFECTING WIPES 
wet wipes swab
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74439-004
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL75 g  in 100 g
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.1 g  in 100 g
CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P) (CETYLPYRIDINIUM - UNII:CUB7JI0JV3) CETYLPYRIDINIUM CHLORIDE0.05 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
DIDECYLDIMONIUM CHLORIDE (UNII: JXN40O9Y9B)  
WATER (UNII: 059QF0KO0R)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
GLYCERIN (UNII: PDC6A3C0OX)  
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:74439-004-0148 g in 1 PACKAGE; Type 0: Not a Combination Product06/01/2020
2NDC:74439-004-02450 g in 1 PACKAGE; Type 0: Not a Combination Product06/01/2020
3NDC:74439-004-03930 g in 1 CANISTER; Type 0: Not a Combination Product06/01/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A04/13/2020
ANTIBACTERIAL WET WIPES 
wet wipes swab
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74439-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.156 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
BRONOPOL (UNII: 6PU1E16C9W)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
WATER (UNII: 059QF0KO0R)  
DIDECYLDIMONIUM CHLORIDE (UNII: JXN40O9Y9B)  
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:74439-001-0348 g in 1 PACKET; Type 0: Not a Combination Product04/13/2020
2NDC:74439-001-04130 g in 1 PACKET; Type 0: Not a Combination Product04/13/2020
3NDC:74439-001-0210 in 1 PACKET04/13/2020
3NDC:74439-001-015 g in 1 BAG; Type 1: Convenience Kit of Co-Package
4NDC:74439-001-06340 g in 1 PACKET; Type 0: Not a Combination Product04/13/2020
5NDC:74439-001-07450 g in 1 PACKET; Type 0: Not a Combination Product04/13/2020
6NDC:74439-001-08560 g in 1 CANISTER; Type 0: Not a Combination Product04/13/2020
7NDC:74439-001-05286 g in 1 PACKET; Type 0: Not a Combination Product04/13/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A04/13/2020
ALCOHOL WET TISSUE 
wet tissue swab
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74439-003
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL75 g  in 100 g
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.1 g  in 100 g
CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P) (CETYLPYRIDINIUM - UNII:CUB7JI0JV3) CETYLPYRIDINIUM CHLORIDE0.05 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
DIDECYLDIMONIUM CHLORIDE (UNII: JXN40O9Y9B)  
WATER (UNII: 059QF0KO0R)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
GLYCERIN (UNII: PDC6A3C0OX)  
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:74439-003-0148 g in 1 PACKAGE; Type 0: Not a Combination Product06/01/2020
2NDC:74439-003-02450 g in 1 PACKAGE; Type 0: Not a Combination Product06/01/2020
3NDC:74439-003-03930 g in 1 CANISTER; Type 0: Not a Combination Product06/01/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A04/13/2020
Labeler - SHANDONG PROVINCE RUNHE SANITARY MATERIALS CO.,LTD. (421350449)

Revised: 10/2021
Document Id: cf758240-23b4-907c-e053-2995a90aa931
Set id: a2e83e97-28c3-5d10-e053-2995a90a72ea
Version: 6
Effective Time: 20211028
 
SHANDONG PROVINCE RUNHE SANITARY MATERIALS CO.,LTD.