FDA.reportPublic FDA data

G AND Y ANTIBACTERIAL WET WIPES

Manufacturer
ERUSLU SAGLIK URUNLERI SANAYI VE TICARET ANONIM SIRKETI
Effective date
2022-02-01
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:47:53

Label at a glance#

ProductG AND Y ANTIBACTERIAL WET WIPES
Active ingredientBENZALKONIUM CHLORIDE
Label structure9 sections

Indications and uses

For handwashing to decrease bacteria on the skin

Dosage and administration

•  Storage . Store at room temperature. • Dispensing . Remove seal band. Lift tab at front of lid. Pull out wipe and reseal lid. Close lid to retain moisture. •  Use . Apply wipe thoroughly to hands as desired. Allow to dry without wiping. •  Disposal . Dispose of used wipes in trash receptacle after use. Do not flush.

Storage and handling

Production Date, Expiry Date and Lot Number on side

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium Chloride 0.13% w/w

Purpose

OTC - PURPOSE SECTION

Antibacterial

Uses

INDICATIONS & USAGE SECTION

For handwashing to decrease bacteria on the skin

Warning

WARNINGS SECTION

For external use only

Do not use

▪ in the eyes.
▪ if you are allergic to any of the ingredients.

When using this product  if eye contact occurs, rinse eyes thoroughly with water.

Stop use and ask a doctor if irritation and redness develop and persist for more than 72 hours.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.  ▪  If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

• Storage. Store at room temperature.

• Dispensing. Remove seal band. Lift tab at front of lid. Pull out wipe and reseal lid. Close lid to retain moisture.

• Use. Apply wipe thoroughly to hands as desired. Allow to dry without wiping.

• Disposal. Dispose of used wipes in trash receptacle after use. Do not flush.

Other information

STORAGE AND HANDLING SECTION

Production Date, Expiry Date and Lot Number on side

Inactive ingredients

INACTIVE INGREDIENT SECTION

Benzoic Acid, C12-15 Pareth-12, Dehydroacetic Acid, Fragrance, Glycerin, Phenoxyethanol, Purified Water, Tetrasodium Glutamate Diacetate.

SPL UNCLASSIFIED SECTION

Kills 99.9% of Germs that may cause illness.

6.3 IN x 7.1 IN
(16 cm x 18 cm)

Questions? +1 (862) 257-3339

You may also report serious side effects to this phone number.
Mon-Fri 9:00 AM - 5:00 PM 

Distributed by: G&Y Products, Inc.

25 Shady St, Paterson, NJ 07524

info@gyproduct.com

Country of origin : Turkey

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1038558benzalkonium chloride 0.13 % Medicated PadPSN3
1038558benzalkonium chloride 1.3 MG/ML Medicated PadSCD3
1038558benzalkonium chloride 0.13 % Topical ClothSY3
1038558benzalkonium chloride 0.13 % Topical SwabSY3
1038558benzalkonium chloride 0.13 GM per 100 GM Topical PadSY3
1038558benzalkonium chloride 0.13 GM per 100 GM Topical SwabSY3
1038558benzalkonium chloride 1 ML per 750 ML Topical SwabSY3

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
77613-011-202023-07-28C16284748780-1c7ccaba7-1455-fd44-e053-dadaa90aa01bG&Y Antibacterial Wet Wipes
77613-011-902023-07-28C16284748780-1c7ccaba7-1455-fd44-e053-dadaa90aa01bG&Y Antibacterial Wet Wipes
77613-011-202022-02-01C16284748780-1c7ccaba7-1455-fd44-e053-dadaa90aa01bG&Y Antibacterial Wet Wipes
77613-011-902022-02-01C16284748780-1c7ccaba7-1455-fd44-e053-dadaa90aa01bG&Y Antibacterial Wet Wipes
77613-011-202021-07-23C16284748780-1c7ccaba7-1455-fd44-e053-dadaa90aa01bG&Y Antibacterial Wet Wipes
77613-011-902021-07-23C16284748780-1c7ccaba7-1455-fd44-e053-dadaa90aa01bG&Y Antibacterial Wet Wipes

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
77613-011-20G AND Y ANTIBACTERIAL WET WIPES20 in 1 PACKAGECLOTH203
77613-011-20G AND Y ANTIBACTERIAL WET WIPES3.5 mL in 1 PACKETCLOTH3.53
77613-011-90G AND Y ANTIBACTERIAL WET WIPES90 in 1 PACKAGECLOTH903
77613-011-90G AND Y ANTIBACTERIAL WET WIPES3.5 mL in 1 PACKETCLOTH3.53

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
77613-011G AND Y ANTIBACTERIAL WET WIPES (BENZALKONIUM CHLORIDE) CLOTH [ERUSLU SAGLIK URUNLERI SANAYI VE TICARET ANONIM SIRKETI]3Legacy NDC, 4 package rows20220202_6eab09eb-0f89-4e22-ac59-0dfcad0223fe.zip

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
77613-01177613-011-20, 77613-011-90

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB
BENZOIC ACID8SKN0B0MIMIACT
C12-15 PARETH-12131316X18LIACT
DEHYDROACETIC ACID2KAG279R6RIACT
GLYCERINPDC6A3C0OXIACT
PHENOXYETHANOLHIE492ZZ3TIACT
WATER059QF0KO0RIACT
TETRASODIUM GLUTAMATE DIACETATE5EHL50I4MYIACT

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
f19f7385-91f4-4b1b-b7e7-8778c4a39d146eab09eb-0f89-4e22-ac59-0dfcad0223fe2022-02-01WarningsExact identifier
spl id: f19f7385-91f4-4b1b-b7e7-8778c4a39d14
spl set id: 6eab09eb-0f89-4e22-ac59-0dfcad0223fe

Reported adverse events (FAERS/openFDA)#

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