DISINFECTING WIPES- benzalkonium chloride,didecyl dimethyl ammonium chloride cloth 
CROWN (YANGZHOU) HEALTH & BEAUTY 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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DISINFECTING WIPES

DISINFECTING WIPES

Active Ingredient(s)

Benzalkonium Chloride 0.2g/100g
DiDecyl dimethyl ammonium chloride 0.2g/100g

Purpose: Antiseptic

Purpose

Antiseptic, DISINFECTING WIPES

Use

DISINFECTING WIPES to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Warnings

For external use only. Flammable. Keep away from heat or flame

Do not use

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.
Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Other information

Inactive ingredients

Phenoxyethanol
Ethylhexyl glycerin
Propylene Glycol
Glycerin
Purified Water

Package Label - Principal Display Panel

1

DISINFECTING WIPES 
benzalkonium chloride,didecyl dimethyl ammonium chloride cloth
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75328-401
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIDECYLDIMONIUM CHLORIDE (UNII: JXN40O9Y9B) (DIDECYLDIMONIUM - UNII:Z7F472XQPA) DIDECYLDIMONIUM CHLORIDE0.2   in 100 
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.2   in 100 
Inactive Ingredients
Ingredient NameStrength
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:75328-401-0175 in 1 DRUM; Type 0: Not a Combination Product03/30/2020
2NDC:75328-401-0280 in 1 DRUM; Type 0: Not a Combination Product03/30/2020
3NDC:75328-401-03100 in 1 DRUM; Type 0: Not a Combination Product03/30/2020
4NDC:75328-401-04120 in 1 DRUM; Type 0: Not a Combination Product03/30/2020
5NDC:75328-401-05160 in 1 DRUM; Type 0: Not a Combination Product03/30/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A03/30/2020
Labeler - CROWN (YANGZHOU) HEALTH & BEAUTY CO., LTD. (542978427)
Establishment
NameAddressID/FEIBusiness Operations
CROWN (YANGZHOU) HEALTH & BEAUTY CO., LTD.542978427manufacture(75328-401)

Revised: 7/2020
Document Id: aaf30840-d075-79a7-e053-2a95a90aeac9
Set id: aaf30840-d076-79a7-e053-2a95a90aeac9
Version: 1
Effective Time: 20200720
 
CROWN (YANGZHOU) HEALTH & BEAUTY CO., LTD.