HAND SANITIZING 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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77720-003 HAND SANITIZING WIPES 0.3% BENZALKONIUM CHLORIDE

Active Ingredient

Benzalkonium Chloride 0.3%

Purpose

Antibacterial

USE

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.

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

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

11

HAND SANITIZING WIPES 
benzalkonium chloride cloth
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77720-003
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)  
QUATERNIUM-52 (UNII: 588EQF3H1P)  
PEG-75 LANOLIN (UNII: 09179OX7TB)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P)  
PEG-8 DIMETHICONE (UNII: GIA7T764OD)  
DISODIUM COCOAMPHODIACETATE (UNII: 18L9G3U51M)  
DISODIUM EDTA-COPPER (UNII: 6V475AX06U)  
CHAMOMILE (UNII: FGL3685T2X)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:77720-003-0110 in 1 BAG06/23/2020
14.05 g in 1 POUCH; Type 0: Not a Combination Product
2NDC:77720-003-0215 in 1 BAG06/23/2020
24.05 g in 1 POUCH; Type 0: Not a Combination Product
3NDC:77720-003-0320 in 1 BAG06/23/2020
34.05 g in 1 POUCH; Type 0: Not a Combination Product
4NDC:77720-003-0425 in 1 BAG06/23/2020
44.05 g in 1 POUCH; Type 0: Not a Combination Product
5NDC:77720-003-0530 in 1 BAG06/23/2020
54.05 g in 1 POUCH; Type 0: Not a Combination Product
6NDC:77720-003-0650 in 1 BAG06/23/2020
64.05 g in 1 POUCH; Type 0: Not a Combination Product
7NDC:77720-003-0775 in 1 CANISTER06/23/2020
74.05 g in 1 POUCH; Type 0: Not a Combination Product
8NDC:77720-003-08100 in 1 BAG06/23/2020
84.05 g in 1 POUCH; Type 0: Not a Combination Product
9NDC:77720-003-091 in 1 BAG06/23/2020
94.05 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 finalpart333A06/23/2020
Labeler - Skaffles Group Limited Liability Company (831115642)
Establishment
NameAddressID/FEIBusiness Operations
Jinhua Aidi Daily Chemical Co., Ltd 547506401manufacture(77720-003)

Revised: 6/2020
Document Id: a8ca19e2-5e66-961b-e053-2995a90a00c9
Set id: a8ca12db-8b83-934a-e053-2995a90a4e28
Version: 1
Effective Time: 20200623
 
Skaffles Group Limited Liability Company