ABUTOL SANITIZING LEMON AND MINT- benzalkonium chloride spray

Abutol Sanitizing Lemon and mint by

Drug Labeling and Warnings

Abutol Sanitizing Lemon and mint by is a Otc medication manufactured, distributed, or labeled by ATAK FARMA KOZMETIK VE KIMYA SANAYI TICARET ANONIM SIRKETI. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient

Benzalkonium chloride 0.13%

Purpose

Antiseptic

Uses

Hand sanitizer to decrease bacteria on the skin
Recommended for repeated use
For use when soap and water are not available

Warnings

For external use only. Protect from the sunlight.

Do not use
on children less than 2 months of age
on open skin wounds

When using this product Avoid use on/or around eyes, ears, mouth, broken/ irritated skin or large areas of body. In case of a contact with eyes, rinse thoroughly with water several minutes. do not inhale or ingest

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

Directions

Hold upright at 6-7 inches away from surface and spray evenly. Repeat application a necessary when using this product to avoid swallowing

Other information

store between 15-30 C (59-86F)

Inactive ingredients

Aqua, FD&C Blue No.1, FD&C Red No.40, Glycerin, Parfum.

SPL UNCLASSIFIED SECTION

Kills 99.99% of Germs *

* KILLS 99.9 OF MOST COMMON GERMS, BACTERIA AND VIRUSES.

Distributed by:
American Brands and More LLC,
Wood Ridge, NJ 07075

Made in TURKEY
You may also report any serious side effects to
PO Box 328, Wood Ridge, NJ 07075-328

Packaging

INGREDIENTS AND APPEARANCE

ABUTOL SANITIZING LEMON AND MINT 
benzalkonium chloride spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 77418-802
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 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C RED NO. 40 (UNII: WZB9127XOA)
GLYCERIN (UNII: PDC6A3C0OX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 77418-802-10	1000 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	11/06/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	11/06/2020

Labeler - ATAK FARMA KOZMETIK VE KIMYA SANAYI TICARET ANONIM SIRKETI (566218248)

Establishment
Name	Address	ID/FEI	Business Operations
ATAK FARMA KOZMETIK VE KIMYA SANAYI TICARET ANONIM SIRKETI		566218248	manufacture(77418-802)