BIG WIPES MULTI-PURPOSE- benzalkonium chloride cloth

BIG WIPES Multi-Purpose by

Drug Labeling and Warnings

BIG WIPES Multi-Purpose by is a Otc medication manufactured, distributed, or labeled by Sycamore USA Inc., WET NAPS LTD.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Benzalkonium Chloride 0.13%

Purpose

Antibacterial

Uses

Ceans hands and reduces 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

• 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 GUTARATE, DIMETHYL ADIPATE, DIMETHYL METHYLGLUTARATE. 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

PRINCIPAL DISPLAY PANEL

BIG WIPES

MULTI-PURPOSE

ANTIBACTERIAL HAND WIPES

PRO+

CLEANS

PAINT

ADHESIVE

SILICONE

POLY FOAM

GAP FILL

OIL

GRIME

and MORE FROM

YOUR HANDS

4x4 FORMULA

TOUGH ON

GRIME

KIND TO YOUR HANDS

NDC # 79705-002-04

ANTIBACTERIAL

check mark

Hand Wipes

NSF

Nonfood Compound

E4

DERMATOLOGICALLY TESTED

80

WIPES (8" x 12")

HAND SANITIZER WIPES

INGREDIENTS AND APPEARANCE

BIG WIPES MULTI-PURPOSE 
benzalkonium chloride cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 79705-002
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	1.3 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
METHYL SOYATE (UNII: 808DL597QP)
DIMETHYL GLUTARATE (UNII: 1I9VFA346P)
DIMETHYL METHYLGLUTARATE (UNII: 728OFW5M9G)
WATER (UNII: 059QF0KO0R)
DIMETHYL SUCCINATE (UNII: 914I2127JR)
DIMETHYL ADIPATE (UNII: BY71RX0R62)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
PROPANEDIOL (UNII: 5965N8W85T)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
DIDECYLDIMONIUM CHLORIDE (UNII: JXN40O9Y9B)
PEG-75 LANOLIN (UNII: 09179OX7TB)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
GLYCERIN (UNII: PDC6A3C0OX)
ALCOHOL (UNII: 3K9958V90M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 79705-002-01	4 mL in 1 POUCH; Type 0: Not a Combination Product	08/31/2020
2	NDC: 79705-002-03	110 mL in 1 CANISTER; Type 0: Not a Combination Product	08/31/2020
3	NDC: 79705-002-04	310 mL in 1 CANISTER; Type 0: Not a Combination Product	08/31/2020
4	NDC: 79705-002-06	1161 mL in 1 CANISTER; Type 0: Not a Combination Product	08/31/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	08/31/2020	10/31/2025

Labeler - Sycamore USA Inc. (078589316)

Establishment
Name	Address	ID/FEI	Business Operations
WET NAPS LTD.		514650902	manufacture(79705-002)