OTC Medication Information: Ultra Compact Antibacterial Wet Wipes

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.

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:

Label
(click image for full-size original)

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 DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BENZALKONIUM CHLORIDE (BENZALKONIUM) BENZALKONIUM CHLORIDE 1.3 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER
PHENOXYETHANOL
GLYCERIN
COCAMIDOPROPYL BETAINE
BENZOIC ACID
CETEARYL ISONONANOATE
EDETATE SODIUM
DEHYDROACETIC ACID
POLYOXYL 20 CETOSTEARYL ETHER
CETOSTEARYL ALCOHOL
PANTHENOL
DISODIUM LAURETH SULFOSUCCINATE
GLYCERYL MONOSTEARATE
ALLANTOIN
CETEARETH-12
CETYL PALMITATE
CITRIC ACID MONOHYDRATE
POTASSIUM SORBATE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:81044-000-01 100 PATCH in 1 BOX contains a PATCH
1 3.8968 mL in 1 PATCH This package is contained within the BOX (81044-000-01)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333E 11/16/2020
Labeler — ARSAN KIMYA SANAYI VE TICARET ANONIM SIRKETI (533149844)
Establishment
Name Address ID/FEI Operations
ARSAN KIMYA SANAYI VE TICARET ANONIM SIRKETI 533149844 manufacture (81044-000)

Revised: 11/2020 ARSAN KIMYA SANAYI VE TICARET ANONIM SIRKETI

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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