ANTISEPTIC HAND WIPES- polyaminopropyl biguanide, benzalkonium and cetylpyridinium swab 
Jiebao Daily Chemical (Xiangxi)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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Wipes

Active Ingredient

POLYAMINOPROPYL BIGUANIDE 1.5%

BENZALKONIUM CHLORIDE 0.2%

CETYLPYRIDINIUM CHLORIDE 0.1%

Purpose

Antiseptic

USE

Warning

Other Information:

use in well ventilated areas; keep away from heat/sparks//open flames/hot surfaces

If swallowed, get medical help or contact a Poison Contrl Center right away.

Directions

Inactive ingredients

citric acid, disodium EDTA, Lauryl Pyridinium chloride, water

label image

ANTISEPTIC HAND WIPES 
polyaminopropyl biguanide, benzalkonium and cetylpyridinium swab
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78724-008
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
POLYAMINOPROPYL BIGUANIDE (UNII: DT9D8Z79ET) (POLYAMINOPROPYL BIGUANIDE - UNII:DT9D8Z79ET) POLYAMINOPROPYL BIGUANIDE15 mg  in 1 g
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE2 mg  in 1 g
CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P) (CETYLPYRIDINIUM - UNII:CUB7JI0JV3) CETYLPYRIDINIUM CHLORIDE1 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
water (UNII: 059QF0KO0R)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
LAURYLPYRIDINIUM CHLORIDE (UNII: KJM5A6A3YL)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:78724-008-0180 in 1 BAG07/31/2020
14.70 g in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A06/04/2020
Labeler - Jiebao Daily Chemical (Xiangxi)Co.,Ltd (405235017)
Establishment
NameAddressID/FEIBusiness Operations
Jiebao Daily Chemical (Xiangxi)Co.,Ltd405235017manufacture(78724-008)

Revised: 7/2020
Document Id: 16ea284a-6805-4f0c-87b4-dde050e2c1f9
Set id: c70533ec-8a72-493a-bc2b-b5fe2281d0ec
Version: 1
Effective Time: 20200731
 
Jiebao Daily Chemical (Xiangxi)Co.,Ltd