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

G AND Y ANTIBACTERIAL HAND WIPES- benzalkonium chloride cloth
ERUSLU SAGLIK URUNLERI SANAYI VE TICARET ANONIM SIRKETI

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.

Drug Facts

Active ingredients

Benzalkonium Chloride 0.13% w/w

Purpose

Antibacterial

Uses

For handwashing to decrease bacteria on the skin

Warning

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.

Directions

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

Production Date, Expiry Date and Lot Number on side

Inactive ingredients

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

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

image description
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G AND Y ANTIBACTERIAL HAND WIPES
benzalkonium chloride cloth
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:77613-010
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 100 mL
Inactive Ingredients
Ingredient Name Strength
BENZOIC ACID
C12-15 PARETH-12
DEHYDROACETIC ACID
GLYCERIN
PHENOXYETHANOL
WATER
TETRASODIUM GLUTAMATE DIACETATE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:77613-010-20 20 PACKET in 1 PACKAGE contains a PACKET
1 3.5 mL in 1 PACKET This package is contained within the PACKAGE (77613-010-20)
2 NDC:77613-010-90 90 PACKET in 1 PACKAGE contains a PACKET
2 3.5 mL in 1 PACKET This package is contained within the PACKAGE (77613-010-90)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333A 05/14/2020
Labeler — ERUSLU SAGLIK URUNLERI SANAYI VE TICARET ANONIM SIRKETI (565415460)
Establishment
Name Address ID/FEI Operations
ERUSLU SAGLIK URUNLERI SANAYI VE TICARET ANONIM SIRKETI 565415460 manufacture (77613-010)

Revised: 05/2020 ERUSLU SAGLIK URUNLERI SANAYI VE TICARET ANONIM SIRKETI

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