G AND Y ANTIBACTERIAL WET WIPES: Package Insert and Label Information

G AND Y ANTIBACTERIAL WET WIPES- benzalkonium chloride cloth
G&Y PRODUCTS 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.

Benzalkonium Chloride 0.13% w/w

Purpose

Antibacterial

Uses

For handwashing to decrease bacteria on the skin

Warnings

For external use only

Do not use

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

When using this product

if eye contact occurs, rinse eyes thoroughly with water

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

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

Cloth

Directions

  • Storage: Store at room temperature.
  • Dispensing: Peel back label slowly. Pull out wipe and reseal label. Close label to retain moisture.
  • Use: Apply wipe thoroughly to hands as desired. Allow to dry without wiping.
  • Disposal: Dispose of used wipes in trash receptable after use. Do not flush.

Inactive Ingredients

Benzoic Acid, C12-15 Pareth-12, Dehydroacetic Acid, Fragrance, Glycerin, Phenoxyethanol,

Package label

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

G&Y Antibacterial Wet Wipes 90

G AND Y ANTIBACTERIAL WET WIPES
g and y antibacterial wet wipes cloth
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:80903-013
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BENZALKONIUM CHLORIDE (BENZALKONIUM) BENZALKONIUM CHLORIDE 0.13 g in 3.5 mL
Inactive Ingredients
Ingredient Name Strength
WATER
TETRASODIUM GLUTAMATE DIACETATE
DEHYDROACETIC ACID
PHENOXYETHANOL
C12-15 PARETH-12
BENZOIC ACID
GLYCERIN
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:80903-013-90 90 PACKAGE in 1 PACKAGE contains a PACKAGE
1 3.5 mL in 1 PACKAGE This package is contained within the PACKAGE (80903-013-90)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333A 07/03/2020
Labeler — G&Y PRODUCTS INC. (081236664)
Registrant — G AND Y PRODUCTS INC. (081236664)
Establishment
Name Address ID/FEI Operations
ERUSLU SAGLIK URUNLERI SANAYI VE TICARET ANONIM SIRKETI 565415460 manufacture (80903-013)

Revised: 02/2022 G&Y PRODUCTS INC.

DrugInserts.com provides trustworthy package insert and label information about marketed drugs as submitted by manufacturers to the US Food and Drug Administration. Package information is not reviewed or updated separately by DrugInserts.com. Every individual package label entry contains a unique identifier which can be used to secure further details directly from the US National Institutes of Health and/or the FDA.

As the leading independent provider of trustworthy medication information, we source our database directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. Our material is not intended as a substitute for direct consultation with a qualified health professional.

Terms of Use | Copyright © 2022. All Rights Reserved.