Ultra Compact Antibacterial Wet Wipes

Ultra Compact Antibacterial Wet Wipes by

Drug Labeling and Warnings

Ultra Compact Antibacterial Wet Wipes by is a Otc medication manufactured, distributed, or labeled by ARSAN KIMYA SANAYI VE TICARET ANONIM SIRKETI. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ULTRA COMPACT ANTIBACTERIAL WET WIPES- benzalkonium chloride cloth 
ARSAN KIMYA 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.

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Ultra Compact Antibacterial Wet Wipes

Drug Facts

Active ingredient

Benzalkonium chloride 0.13%

Purpose

Antibacterial

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

Do not use

• on children less than 2 years 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 thoroughly with product and allow to dry without wiping
• supervise children under 6 years of age when using this product to avoid swallowing

Other information

• Store in a cool and dry place at room temperature.
• Keep away from heat/sparks/open flames/hot surfaces.

Inactive ingredients

Aqua (water), Phenoxyethanol, Parfum (Fragrance), Glycerin, Cocamidopropyl Betaine, Benzoic Acid, Cetearyl Isononanoate, Tetrasodium EDTA, Dehydroacetic Acid, Ceteareth-20, Cetearyl Alcohol, Panthenol, Disodium Laureth Sulfosuccinate, Glyceryl Stearate, Allantoin, Ceteareth-12, Cetyl Palmitate, Citric Acid, Potassium Sorbate.

Package Labeling:

ULTRA COMPACT ANTIBACTERIAL WET WIPES 
benzalkonium chloride cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 81044-000
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	1.3 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
GLYCERIN (UNII: PDC6A3C0OX)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
BENZOIC ACID (UNII: 8SKN0B0MIM)
CETEARYL ISONONANOATE (UNII: P5O01U99NI)
EDETATE SODIUM (UNII: MP1J8420LU)
DEHYDROACETIC ACID (UNII: 2KAG279R6R)
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
PANTHENOL (UNII: WV9CM0O67Z)
DISODIUM LAURETH SULFOSUCCINATE (UNII: D6DH1DTN7E)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
ALLANTOIN (UNII: 344S277G0Z)
CETEARETH-12 (UNII: 7V4MR24V5P)
CETYL PALMITATE (UNII: 5ZA2S6B08X)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 81044-000-01	100 in 1 BOX	11/16/2020	12/31/2022
1		3.8968 mL in 1 PATCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	11/16/2020	12/31/2022

Labeler - ARSAN KIMYA SANAYI VE TICARET ANONIM SIRKETI (533149844)

Establishment
Name	Address	ID/FEI	Business Operations
ARSAN KIMYA SANAYI VE TICARET ANONIM SIRKETI		533149844	manufacture(81044-000)

Revised: 1/2023

Document Id: f390bbca-892c-3f1a-e053-2a95a90a583a

34390-5

Set id: b3ebb45f-da24-25d3-e053-2995a90a4737

Version: 2

Effective Time: 20230131

 

ARSA