BIG WIPES Heavy Duty by Sycamore USA Inc. / WET NAPS LTD. / MINIPAC PRODUCTS LTD

BIG WIPES Heavy Duty by

Drug Labeling and Warnings

BIG WIPES Heavy Duty by is a Otc medication manufactured, distributed, or labeled by Sycamore USA Inc., WET NAPS LTD., MINIPAC PRODUCTS LTD. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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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Active Ingredient

Benzalkonium Chloride 0.13%

Purpose

Antibacterial

Uses

Clean hands and reduces bacteria on 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

• Wipe hands
• For best results, clean spills immediately
• Always shut the lid after use and store at room temperature.

Inactive ingredients

WATER (AQUA), DIMETHYL SUCCINATE, DIMETHYL GLUTARATE, DIMETHYL ADIPATE, DIMETHYL METYLGLUTARATE, POLYSORBATE-80, POLYSORBATE-20, DIDECYLDIMONIUM wCHLORIDE, 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

CLEANS PAINT, ADHESIVE,

POLY FOAM, SILICONE,

GAP FILL, OIL, GRIME and MORE

FROM YOUR HANDS

4X4 FORMULA

TOUGH ON

GRIME

KIND TO YOUR HANDS

DERMATOLOGICALLY TESTED

80

WIPES (8 x 12)

HAND SANITIZING WIPES

BIG WIPES HEAVY DUTY 
benzalkonium chloride cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 79705-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	1 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 79705-001-01	6 mL in 1 POUCH; Type 0: Not a Combination Product	08/28/2020
2	NDC: 79705-001-02	123 mL in 1 CANISTER; Type 0: Not a Combination Product	08/28/2020
3	NDC: 79705-001-04	464 mL in 1 CANISTER; Type 0: Not a Combination Product	08/28/2020
4	NDC: 79705-001-05	1391 mL in 1 CANISTER; Type 0: Not a Combination Product	08/28/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	08/28/2020	12/29/2021

Labeler - Sycamore USA Inc. (078589316)

Establishment
Name	Address	ID/FEI	Business Operations
WET NAPS LTD.		514650902	manufacture(79705-001)

Establishment
Name	Address	ID/FEI	Business Operations
MINIPAC PRODUCTS LTD		600067730	manufacture(79705-001)

Revised: 12/2021

Document Id: d44c370d-3e8d-7664-e053-2a95a90a587e

34390-5

Set id: adf6693f-89a4-b480-e053-2995a90a09f3

Version: 2

Effective Time: 20211229