BIG WIPES HEAVY DUTY- benzalkonium chloride cloth 
Sycamore USA Inc.

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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BIG WIPES

Heavy-Duty

Active Ingredient

Benzalkonium Chloride 0.13%

Purpose

Antibacterial

Uses

Cleans hands and reduce bacteria on the skin

Warnings

For external use only

When using this product do not use in or around eyes. May irritate eyes.

IF IN EYES rinse well for 15 minutes

KEEP OUT OF REACH OF CHILDREN

Directions

Open foil seal and pull the center wipe through the lid

Inactive ingredients

WATER (AQUA), DIMETHYL SUCCINATE, DIMETHYL GLUTARATE, DIMETHYL ADIPATE, DIMETHYL METYLGLUTARATE, POLYSORBATE-80, POLYSORBATE-20, DIDECYLDIMONIUM CHLORIDE, GLYCERIN, METHYL SOYATE, PEG-75 LANOLIN, ALCOHOL, CITRIC ACID, SODIUM CITRATE, ALOE BARBADENSIS LEAF JUICE, TOCOPHERYL ACETATE (VITAMIN E), PROPANEDIOL, PARFUM.

Questions?

Call (770) 628-0286 or visit www.bigwipesusa.com

BIG WIPES

HEAVY-DUTY

ANTIBACTERIAL HAND WIPES

PRO+

CLEANS

PAINT

ADHESIVE

SILICONE

PLY FOAM

GAP FILL

OIL

GRIME

and MORE

FROM YOUR HANDS

NDC #79705-003-04

ANTIBACTERIAL

Hand Wipes

NSF

Nonfood Compound

E4

DERMATOLOGICALLY TESTED

80

WIPES (8" x 12")

HAND SANITIZING WIPES

container label2

BIG WIPES HEAVY DUTY 
benzalkonium chloride cloth
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79705-003
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE1.3 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
GLYCERIN (UNII: PDC6A3C0OX)  
PROPANEDIOL (UNII: 5965N8W85T)  
WATER (UNII: 059QF0KO0R)  
METHYL SOYATE (UNII: 808DL597QP)  
PEG-75 LANOLIN (UNII: 09179OX7TB)  
DIMETHYL ADIPATE (UNII: BY71RX0R62)  
DIMETHYL METHYLGLUTARATE (UNII: 728OFW5M9G)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
ALCOHOL (UNII: 3K9958V90M)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
DIMETHYL SUCCINATE (UNII: 914I2127JR)  
DIMETHYL GLUTARATE (UNII: 1I9VFA346P)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
DIDECYLDIMONIUM CHLORIDE (UNII: JXN40O9Y9B)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:79705-003-016 mL in 1 POUCH; Type 0: Not a Combination Product08/28/2020
2NDC:79705-003-02123 mL in 1 CANISTER; Type 0: Not a Combination Product08/28/2020
3NDC:79705-003-04464 mL in 1 CANISTER; Type 0: Not a Combination Product08/28/2020
4NDC:79705-003-051391 mL in 1 CANISTER; Type 0: Not a Combination Product08/28/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A08/28/202010/31/2025
Labeler - Sycamore USA Inc. (078589316)
Establishment
NameAddressID/FEIBusiness Operations
WET NAPS LTD.514650902manufacture(79705-003)

Revised: 11/2022
Document Id: ee270a38-0ec5-0b44-e053-2a95a90a2ba5
Set id: b17e97e7-aedf-2747-e053-2995a90ab36b
Version: 3
Effective Time: 20221123
 
Sycamore USA Inc.