ANTIBACTERIAL HAND WIPES- benzalkonium chloride cloth 
Skaffles Group Limited Liability Company

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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77720-019 CLEANZE Antibacterial Hand Wipes 0.13% BENZALKONIUM CHLORIDE

Active Ingredient

Benzalkonium Chloride 0.13%

Purpose

Antibacterial

USE

For external use only .

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

Warning

For external use only.

Do not use
If you are allergic to any of the ingredients. In the eyes; if contact occurs, rinse thoroughly with water.
Discontinue use if irritation and redness develop. If condition persists for more than 72 hours consult a doctor.

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

Directions

Directions● Adults and children 2 yrs and over,
apply to hands and allow skin to dry without wiping.
●Children under 2, ask doctor before use.

Inactive ingredients

Aloe Barbadensis Leaf Juice, Cetylpyridinium Chloride, Chamomilla Recutita(Matricaria)Flower Extract, Citric Acid, Disodium Cocoamphodiacetate, Disodium EDTA, PEG-75 Lanolin,PEG-8Dimethicone,Phenoxyethanol,Potassium Sorbate, Quatermium-52, Sodium Benzoate, Water.

1

ANTIBACTERIAL HAND WIPES 
benzalkonium chloride cloth
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77720-019
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
WATER (UNII: 059QF0KO0R)  
QUATERNIUM-52 (UNII: 588EQF3H1P)  
PEG-75 LANOLIN (UNII: 09179OX7TB)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P)  
PEG-8 DIMETHICONE (UNII: GIA7T764OD)  
DISODIUM COCOAMPHODIACETATE (UNII: 18L9G3U51M)  
DISODIUM EDTA-COPPER (UNII: 6V475AX06U)  
CHAMOMILE (UNII: FGL3685T2X)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:77720-019-011 in 1 BAG01/15/2021
12.7 g in 1 NOT APPLICABLE; Type 0: Not a Combination Product
2NDC:77720-019-0215 in 1 POUCH01/15/2021
240.5 g in 1 NOT APPLICABLE; Type 0: Not a Combination Product
3NDC:77720-019-0320 in 1 POUCH01/15/2021
354 g in 1 NOT APPLICABLE; Type 0: Not a Combination Product
4NDC:77720-019-0425 in 1 POUCH01/15/2021
467.5 g in 1 NOT APPLICABLE; Type 0: Not a Combination Product
5NDC:77720-019-0530 in 1 POUCH01/15/2021
581 g in 1 NOT APPLICABLE; Type 0: Not a Combination Product
6NDC:77720-019-0650 in 1 POUCH01/15/2021
6135 g in 1 NOT APPLICABLE; Type 0: Not a Combination Product
7NDC:77720-019-0775 in 1 POUCH01/15/2021
7202.5 g in 1 NOT APPLICABLE; Type 0: Not a Combination Product
8NDC:77720-019-08100 in 1 POUCH01/15/2021
8270 g in 1 NOT APPLICABLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A01/15/2021
Labeler - Skaffles Group Limited Liability Company (831115642)
Establishment
NameAddressID/FEIBusiness Operations
Dalian Da Xin Nonwoven Technology Co., Ltd.415363991manufacture(77720-019)

Revised: 1/2021
Document Id: b8fafd62-bfaa-4e3e-e053-2995a90afb87
Set id: b8fafb36-c6af-1406-e053-2995a90ac676
Version: 1
Effective Time: 20210115
 
Skaffles Group Limited Liability Company