CLEANSING DISINFECTION WIPES- cleansing disinfection wipes cloth 
Guangdong Bolicen Bio-Technology 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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CLEANSING&DISINFECTION WIPES

Active Ingredient(s)

Alcohol 10% w/w

Benzalkonium Chlorid 0. 1%w/w

Poly( hexamethylenebiguanide )hydro-chloride 0.05%w/w

Didecyl Dimethylammonium Chloride 0.3%w/w

Purpose

Antiseptic

Use

USE FOR HAND AND SKIN SURFACE DISINFECTING AND CLEANSING

Warnings

For extemal use only. Keep away from sunlight, store in a cool, dry place

Do not use

In children less than 2 months of age
On open skin wounds

When using this product keep out of eyes and sore or broken skin, If contact with eyes occurs, rinse thoroughly with water.top use and ask a doctor if irritation or rash occurs, These may be signs of a serious condition Keep out of reach of children. Get medical help or contact a Poison Control Center right away if needed

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

Keep out of reach of children. Get medical help or contact a Poison Control Center right away if needed

Directions

Open lid, For first time user, remove tamper evident seal, Pullout wipes as needed. Close the lid after use each time top revent moisture loss

Other information

Do not store above 40 °C. May discolor some fabrics and surfaces
Store between15-30°C

Inactive ingredients

Water

Package Label - Principal Display Panel

810305080100

CLEANSING DISINFECTION WIPES 
cleansing disinfection wipes cloth
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78293-008
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.1   in 100 
POLIHEXANIDE (UNII: 322U039GMF) (POLIHEXANIDE - UNII:322U039GMF) POLIHEXANIDE0.05   in 100 
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL10   in 100 
DIDECYLDIMONIUM CHLORIDE (UNII: JXN40O9Y9B) (DIDECYLDIMONIUM - UNII:Z7F472XQPA) DIDECYLDIMONIUM CHLORIDE0.3   in 100 
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:78293-008-018 in 1 BAG; Type 0: Not a Combination Product07/12/2020
2NDC:78293-008-0210 in 1 BAG; Type 0: Not a Combination Product07/12/2020
3NDC:78293-008-0330 in 1 BAG; Type 0: Not a Combination Product07/12/2020
4NDC:78293-008-0450 in 1 BAG; Type 0: Not a Combination Product07/12/2020
5NDC:78293-008-0580 in 1 BAG; Type 0: Not a Combination Product07/12/2020
6NDC:78293-008-06100 in 1 BAG; Type 0: Not a Combination Product07/12/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A07/12/2020
Labeler - Guangdong Bolicen Bio-Technology Co., Ltd. (554525110)
Establishment
NameAddressID/FEIBusiness Operations
Guangdong Bolicen Bio-Technology Co., Ltd.554525110manufacture(78293-008)

Revised: 7/2020
Document Id: aa35d259-4960-5084-e053-2995a90a28f9
Set id: aa35d4b4-1df1-d1b5-e053-2a95a90a246d
Version: 1
Effective Time: 20200711
 
Guangdong Bolicen Bio-Technology Co., Ltd.