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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77720-007 WIPES 0.3% BENZALKONIUM CHLORIDE

Active Ingredient

Benzalkonium Chloride 0.3%

Purpose

Antibacterial

USE

Use for hand sanitizing 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.

Keep out of reach of children.

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

Water, Phenoxyethanol,Sodium benzoate, Propylene glycol, Aloe barbadensis leaf juice, PEG-8 dimethicone, Disodium edta, Citric acid.

1

WIPES 
benzalkonium chloride cloth
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77720-007
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.3 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
PEG-8 DIMETHICONE (UNII: GIA7T764OD)  
DISODIUM EDTA-COPPER (UNII: 6V475AX06U)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:77720-007-011 in 1 BAG07/20/2020
12.7 g in 1 NOT APPLICABLE; Type 0: Not a Combination Product
2NDC:77720-007-0215 in 1 POUCH07/20/2020
22.7 g in 1 NOT APPLICABLE; Type 0: Not a Combination Product
3NDC:77720-007-0320 in 1 POUCH07/20/2020
32.7 g in 1 NOT APPLICABLE; Type 0: Not a Combination Product
4NDC:77720-007-0425 in 1 POUCH07/20/2020
42.7 g in 1 NOT APPLICABLE; Type 0: Not a Combination Product
5NDC:77720-007-0530 in 1 POUCH07/20/2020
52.7 g in 1 NOT APPLICABLE; Type 0: Not a Combination Product
6NDC:77720-007-0650 in 1 POUCH07/20/2020
62.7 g in 1 NOT APPLICABLE; Type 0: Not a Combination Product
7NDC:77720-007-0775 in 1 POUCH07/20/2020
72.7 g in 1 NOT APPLICABLE; Type 0: Not a Combination Product
8NDC:77720-007-08100 in 1 POUCH07/20/2020
82.7 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 finalpart333A07/20/2020
Labeler - Skaffles Group Limited Liability Company (831115642)
Establishment
NameAddressID/FEIBusiness Operations
Dalian Da Xin Nonwoven Technology Co.,Ltd.415363991manufacture(77720-007)

Revised: 7/2020
Document Id: ab25c982-d5d5-d4d8-e053-2a95a90adc7a
Set id: ab25ca2d-7758-1b02-e053-2a95a90a5a63
Version: 1
Effective Time: 20200723
 
Skaffles Group Limited Liability Company