FRESHMAKER ANTISEPTIC WET WIPES- benzalkonium chloride cloth

FRESHMAKER ANTISEPTIC WET WIPES by

Drug Labeling and Warnings

FRESHMAKER 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

ANTISEPTIC AGENT

BENZALKONIUM CHLORIDE

Manufactured by : Fulya Kozmetik Islak Mendil Iml. ve Paz.Ltd.Sti.

Kirac Osmangazi Kucuk Ayazma Street No:17

34522, Esenyurt/ISTANBUL/TURKEY

P: +90 212 689 28 28 Fax: +90 212 689 82 28

Made in TURKEY

Web: http://www.fulyakozmetik.com

e-mail: fulya@fulyakozmetik.com.tr

Lot No:

Expiry:

You may also report any serious side effects to 

PO BOX 328, Wood Ridge, NJ 07075-328

Packaging

INGREDIENTS AND APPEARANCE

FRESHMAKER ANTISEPTIC WET WIPES 
benzalkonium chloride cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 78850-120
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: 78850-120-15	15 in 1 PACKET	07/01/2020
1		2.87 g in 1 PACKAGE; Type 0: Not a Combination Product
2	NDC: 78850-120-72	72 in 1 PACKET	07/01/2020
2		3.6 g in 1 PACKAGE; Type 0: Not a Combination Product
3	NDC: 78850-120-00	120 in 1 PACKET	07/01/2020
3		3.6 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	07/01/2020

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(78850-120)