HAND WIPES- benzalkonium chloride cloth 
Enping Jiaxin Daily Necessities 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.

----------

Hand Wipes

Active Ingredient(s)

Benzalkonium chloride 0.13%. Purpose: Antiseptic

Purpose

Antiseptic, Hand Wipes

Use

Hand 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

Glycerin;

Polyaminopropyl Biguanide;

Propylene Glycol;

Aloe Barbadensis Leaf Juice;

Decyl glucoside;

Polysorbate 20;

Cetylpyridinium Chloride;

Water.

Package Label - Principal Display Panel

Label

HAND WIPES 
benzalkonium chloride cloth
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75111-601
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.13   in 100 
Inactive Ingredients
Ingredient NameStrength
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
DECYL GLUCOSIDE (UNII: Z17H97EA6Y)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLYAMINOPROPYL BIGUANIDE (UNII: DT9D8Z79ET)  
WATER (UNII: 059QF0KO0R)  
CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:75111-601-018 in 1 BAG; Type 0: Not a Combination Product03/30/2020
2NDC:75111-601-021 in 1 BAG; Type 0: Not a Combination Product03/30/2020
3NDC:75111-601-035 in 1 BAG; Type 0: Not a Combination Product03/30/2020
4NDC:75111-601-0410 in 1 BAG; Type 0: Not a Combination Product03/30/2020
5NDC:75111-601-0520 in 1 BAG; Type 0: Not a Combination Product03/30/2020
6NDC:75111-601-0625 in 1 BAG; Type 0: Not a Combination Product03/30/2020
7NDC:75111-601-0730 in 1 BAG; Type 0: Not a Combination Product03/30/2020
8NDC:75111-601-0850 in 1 BAG; Type 0: Not a Combination Product03/30/2020
9NDC:75111-601-0960 in 1 BAG; Type 0: Not a Combination Product03/30/2020
10NDC:75111-601-1070 in 1 BAG; Type 0: Not a Combination Product03/30/2020
11NDC:75111-601-1175 in 1 BAG; Type 0: Not a Combination Product03/30/2020
12NDC:75111-601-1280 in 1 BAG; Type 0: Not a Combination Product03/30/2020
13NDC:75111-601-1390 in 1 BAG; Type 0: Not a Combination Product03/30/2020
14NDC:75111-601-14100 in 1 BAG; Type 0: Not a Combination Product03/30/2020
15NDC:75111-601-15120 in 1 BAG; 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 - Enping Jiaxin Daily Necessities Co., Ltd. (403010421)
Establishment
NameAddressID/FEIBusiness Operations
Enping Jiaxin Daily Necessities Co., Ltd.403010421manufacture(75111-601)

Revised: 9/2020
Document Id: aec5e8fb-079a-7fc5-e053-2995a90a7612
Set id: aec5d840-46c0-e5e0-e053-2995a90ae1ed
Version: 1
Effective Time: 20200907
 
Enping Jiaxin Daily Necessities Co., Ltd.