ANITISEPTIC SANITIZING WIPES- benzalkonium chloride cloth 
Jiaxing Qinya Sanitary 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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78601-002 antiseptic sanitizing wipes 0.13% BENZALKONIUM CHLORIDE

Active Ingredient

Benzalkonium Chloride 0.13%

Purpose

Antiseptic

USE

For hand washing to decrease
bacteria on skin
Recommended for repeated use.

Warning

For external use only
Do not use
■Intheeyes.
Stop use and ask doctor if:
Irritation and redness develops
■Condition persists for more than 72 hours

Keep out of reach of children. If
swallowed, get medical help or contact
a poison control center right away.

Directions

■Wet hands thoroughly with product
and allow to dry without wiping.

Inactive ingredients


Aloe Vera, Benzoic Acid,
Cocoamphodiacetate, Disodium, Glycerin,
Tea Tree (Melaleuca Alternifolica) Leaf Oil,
Menthol, Potassium Sorbate, Sodium
Citrate, Water.

1

ANITISEPTIC SANITIZING WIPES 
benzalkonium chloride cloth
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78601-002
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.13 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
MENTHOL (UNII: L7T10EIP3A)  
BENZOIC ACID (UNII: 8SKN0B0MIM)  
DISODIUM COCOAMPHODIACETATE (UNII: 18L9G3U51M)  
WATER (UNII: 059QF0KO0R)  
TEA TREE OIL (UNII: VIF565UC2G)  
GLYCERIN (UNII: PDC6A3C0OX)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:78601-002-04180 in 1 BAG06/05/2020
10.09477 g in 1 POUCH; Type 0: Not a Combination Product
2NDC:78601-002-08180 in 1 PAIL06/05/2020
20.09477 g in 1 POUCH; Type 0: Not a Combination Product
3NDC:78601-002-09250 in 1 PAIL06/05/2020
31.31625 g in 1 POUCH; Type 0: Not a Combination Product
4NDC:78601-002-02900 in 1 BAG06/05/2020
44.7385 g in 1 POUCH; Type 0: Not a Combination Product
5NDC:78601-002-05250 in 1 BAG06/05/2020
50.131625 g in 1 POUCH; Type 0: Not a Combination Product
6NDC:78601-002-031200 in 1 BAG06/05/2020
66.318 g in 1 POUCH; Type 0: Not a Combination Product
7NDC:78601-002-0680 in 1 BAG06/05/2020
70.04212 g in 1 POUCH; Type 0: Not a Combination Product
8NDC:78601-002-07800 in 1 BAG06/05/2020
80.4212 g in 1 POUCH; Type 0: Not a Combination Product
9NDC:78601-002-1020 in 1 BAG06/05/2020
90.01053 g in 1 POUCH; Type 0: Not a Combination Product
10NDC:78601-002-0110 in 1 BAG06/05/2020
100.005265 g in 1 POUCH; Type 0: Not a Combination Product
11NDC:78601-002-11160 in 1 PAIL06/05/2020
110.08424 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 finalpart333A06/05/2020
Labeler - Jiaxing Qinya Sanitary Products Co., Ltd. (413135543)
Establishment
NameAddressID/FEIBusiness Operations
Jiaxing Qinya Sanitary Products Co., Ltd.413135543manufacture(78601-002)

Revised: 9/2020
Document Id: afc95af3-4b2c-1d7b-e053-2995a90a8ec8
Set id: a74c3488-696f-b3a6-e053-2a95a90a9f09
Version: 2
Effective Time: 20200920
 
Jiaxing Qinya Sanitary Products Co., Ltd.