ABUTOL ANTISEPTIC HAND WASH SPRING WATERFALL- benzalkonium chloride liquid

Abutol ANTISEPTIC HAND WASH Spring Waterfall by

Drug Labeling and Warnings

Abutol ANTISEPTIC HAND WASH Spring Waterfall 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 0.12%

Purpose

Antiseptic

Uses

● for handwashing to decrease bacteria on the skin

● recommended for repeated use

Warnings

For external use only

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

When using this product ● do not get into eyes. In case of contact, rinse eyes thoroughly with water

Stop use and ask a doctor if

● irritation and redness develop
● condition persists 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

● wet hands and forearms. Apply 5 millilitre (teaspoonful) or palmful to hands and forearms. Scrub thoroughly for 20 seconds
● rinse and repeat
● supervise children under 6 years of age when using this product to avoid swallowing

Other information

● store between 15-30°C (59-86°F)
● avoid freezing and excessive heat above 40°C (104°F)

Inactive ingredients

Aqua, Benzophenone-4, Citric Acid, Cocamide DEA, Cocamidopropyl Betaine, DMDM Hydantoin, FD&C Blue No.1, Glycerin, Methylchloroisothiazolinone, Methylisothiazolinone, Parfum, Sodium Chloride, Sodium Laureth Sulfate, Tetrasodium EDTA.

SPL UNCLASSIFIED SECTION

with Moisturizer

Spring Waterfall - Cleans and soften hands

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 ANTISEPTIC HAND WASH SPRING WATERFALL 
benzalkonium chloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 77418-205
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.12 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
SULISOBENZONE (UNII: 1W6L629B4K)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
COCO DIETHANOLAMIDE (UNII: 92005F972D)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
DMDM HYDANTOIN (UNII: BYR0546TOW)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
GLYCERIN (UNII: PDC6A3C0OX)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM LAURETH-3 SULFATE (UNII: BPV390UAP0)
EDETATE SODIUM (UNII: MP1J8420LU)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 77418-205-20	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	11/30/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	11/30/2020

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(77418-205)