FDA.reportPublic FDA data

BIG WIPES Heavy Duty

Manufacturer
Sycamore USA Inc. | WET NAPS LTD.
Effective date
2022-11-23
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:51:51

Label at a glance#

ProductBIG WIPES Heavy Duty
Active ingredientBENZALKONIUM CHLORIDE
Label structure8 sections

Indications and uses

Cleans hands and reduce bacteria on the skin

Dosage and administration

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.

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium Chloride 0.13%

Purpose

OTC - PURPOSE SECTION

Antibacterial

Uses

INDICATIONS & USAGE SECTION

Cleans hands and reduce bacteria on the skin

Warnings

WARNINGS SECTION

For external use only

OTC - WHEN USING SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Directions

DOSAGE & ADMINISTRATION SECTION

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

INACTIVE INGREDIENT SECTION

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.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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 label2container label2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79705-003BIG WIPES HEAVY DUTY (BENZALKONIUM CHLORIDE) CLOTH [SYCAMORE USA INC.]3Legacy NDC20221124_b17e97e7-aedf-2747-e053-2995a90ab36b.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 20 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
79705-00379705-003-01, 79705-003-02, 79705-003-04, 79705-003-05

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 18 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALOE VERA LEAFZY81Z83H0XIACT
GLYCERINPDC6A3C0OXIACT
PROPANEDIOL5965N8W85TIACT
WATER059QF0KO0RIACT
METHYL SOYATE808DL597QPIACT
PEG-75 LANOLIN09179OX7TBIACT
DIMETHYL ADIPATEBY71RX0R62IACT
DIMETHYL METHYLGLUTARATE728OFW5M9GIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
ALCOHOL3K9958V90MIACT
SODIUM CITRATE1Q73Q2JULRIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
DIMETHYL SUCCINATE914I2127JRIACT
DIMETHYL GLUTARATE1I9VFA346PIACT
POLYSORBATE 806OZP39ZG8HIACT
POLYSORBATE 207T1F30V5YHIACT
DIDECYLDIMONIUM CHLORIDEJXN40O9Y9BIACT
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ee270a38-0ec5-0b44-e053-2a95a90a2ba5b17e97e7-aedf-2747-e053-2995a90ab36b2022-11-23WarningsExact identifier
spl id: ee270a38-0ec5-0b44-e053-2a95a90a2ba5
spl set id: b17e97e7-aedf-2747-e053-2995a90ab36b

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.