DEEP FRESH ANTIBACTERIAL WET WIPES- benzalkonium chloride cloth

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)

Available from:

AKSAN KOZMETIK SANAYI VE TICARET ANONIM SIRKETI

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

Antibacterial / Antifungal Wet Wipes Antibacterial Wet Wipes to help reduce bacteria that potentially can cause disease. For use when soap and water are not available. - in children less than 2 months of age - on open skin wounds Seek a doctor if redness, swelling, itching, or burning occurs on skin.

Authorization status:

OTC monograph not final

Summary of Product characteristics

DEEP FRESH ANTIBACTERIAL WET WIPES- BENZALKONIUM CHLORIDE CLOTH
AKSAN KOZMETIK 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._
----------
DEEP FRESH ANTIBACTERIAL WET WIPES
This is a hand sanitizer manufactured according to the Temporary
Policy for Preparation
of Certain Alcohol-Based Hand Sanitizer Products During the Public
Health Emergency
(CoViD-19); Guidance for Industry.
The hand sanitizer is manufactured using only the following United
States
Pharmacopoeia (USP) grade ingredients in the preparation of the
product (percentage in
final product formulation) consistent with World Health Organization
(WHO)
recommendations:
a. BENZALKONIUM CHLORIDE (0.23%, weight/weight (w/w)
b. Dehydroacetic Acid
c. Benzoic Acid
d. Lauryl Glucoside
e. Glycerin
f. Propylene Glycol
g. Etidronate Tetrasodium
h. Octadecanoıc Acid, (Octadecylimıno)Di-2,1-Ethanediyl Ester
i. Fatty-Acid Amide Hydrolase 1
j. Phenoxyethanol
k. Dicaprylyl Carbonate
l. Glyceryl Oleate
m. Polysorbate 20
n. Sterile distilled water or boiled cold water.
The firm does not add other active or inactive ingredients. Different
or additional
ingredients may impact the quality and potency of the product.
ACTIVE INGREDIENT(S)
Benzalkonium Chloride 0.23% w/w. Purpose: Antibacterial-Antifungal
PURPOSE
Antibacterial / Antifungal Wet Wipes
USE
Antibacterial Wet Wipes to help reduce bacteria that potentially can
cause disease. For
use when soap and water are not available.
WARNINGS
Keep away from food and animal feeds. 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 inhale the vapour or grains of the
product if occurs. Do
not eat or drink or smoke while using the product. Follow all the
instructions to avoid
risks on human and environmental health. In case of inhaling: Give
fresh air or oxygen. If
you fe