ABUTOL ANTISEPTIC WET WIPES CITRUS GARDEN- benzalkonium chloride cloth

ABUTOL ANTISEPTIC WET WIPES by

Drug Labeling and Warnings

ABUTOL ANTISEPTIC WET WIPES by is a Otc medication manufactured, distributed, or labeled by FULYA KOZMETIK ISLAK MENDIL IMALAT VE PAZARLAMA LIMITED SIRKETI. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient

Benzalkonium chloride 0.13%

Purpose

Antiseptic

Uses

• hand wipes to decrease bacteria on the skin
• recommended for repeated use
• for use when soap and water are not available

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

• open resealable label. Pull out wipes. Close resealable label to prevent drying out wipe hands thoroughly with product and allow to dry
• dispose the wipe after use
• supervise children under 6 years of age when using this product to avoid swallowing
• do not flush

Other information

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

Inactive ingredients

benzoic acid, citric acid, cocamidopropyl betaine, dehydroacetic acid, fragrance, glycerin, PEG-7 glyceryl cocoate, phenoxyethanol, polysorbate 20, propylene glycol, tetrasodium EDTA, water, 

SPL UNCLASSIFIED SECTION

PARIS
ANTISEPTIC AGENT

You may also report any serious side effects to

PO BOX 328, Wood Ridge, NJ 07075-328

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

Packaging

INGREDIENTS AND APPEARANCE

ABUTOL ANTISEPTIC WET WIPES  CITRUS GARDEN
benzalkonium chloride cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 78850-103
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 g

Inactive Ingredients
Ingredient Name	Strength
BENZOIC ACID (UNII: 8SKN0B0MIM)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
DEHYDROACETIC ACID (UNII: 2KAG279R6R)
GLYCERIN (UNII: PDC6A3C0OX)
PEG-7 GLYCERYL COCOATE (UNII: VNX7251543)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
EDETATE SODIUM (UNII: MP1J8420LU)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 78850-103-01	20 in 1 PACKET	08/28/2020
1		2.87 g 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	08/28/2020

Labeler - FULYA KOZMETIK ISLAK MENDIL IMALAT VE PAZARLAMA LIMITED SIRKETI (356117981)

Establishment
Name	Address	ID/FEI	Business Operations
FULYA KOZMETIK ISLAK MENDIL IMALAT VE PAZARLAMA LIMITED SIRKETI		356117981	manufacture(78850-103)