G AND Y ANTIBACTERIAL WET WIPES cloth

G AND Y ANTIBACTERIAL WET WIPES by

Drug Labeling and Warnings

G AND Y ANTIBACTERIAL WET WIPES by is a Otc medication manufactured, distributed, or labeled by G&Y PRODUCTS INC., G AND Y PRODUCTS INC., ERUSLU SAGLIK URUNLERI SANAYI VE TICARET ANONIM SIRKETI. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient(s)

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 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.

Keep out of reach of children

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

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, Purified Water, Tetrasodium Glutamate Diacetate.

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

INGREDIENTS AND APPEARANCE

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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.13 g  in 3.5 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DEHYDROACETIC ACID (UNII: 2KAG279R6R)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY)
C12-15 PARETH-12 (UNII: 131316X18L)
GLYCERIN (UNII: PDC6A3C0OX)
BENZOIC ACID (UNII: 8SKN0B0MIM)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80903-013-20	20 in 1 PACKAGE	07/03/2020
1		3.5 mL in 1 PACKAGE; Type 0: Not a Combination Product

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	Business Operations
ERUSLU SAGLIK URUNLERI SANAYI VE TICARET ANONIM SIRKETI		565415460	manufacture(80903-013)