LARAMED ANTIBACTERIAL ALCOHOL WIPES- alcohol, isopropanol, benzalkonium chloride cloth

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M), ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302), BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)

Tilgjengelig fra:

LARA KOZMETIK HIJYENIK URUNLERI SANAYI VE DIS TICARET ANONIM SIRKETI

Administreringsrute:

TOPICAL

Resept typen:

OTC DRUG

Indikasjoner:

Antiseptic, Hand Sanitizer Hand Sanitizer 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 Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

Autorisasjon status:

OTC monograph not final

Preparatomtale

LARAMED ANTIBACTERIAL ALCOHOL WIPES- ALCOHOL, ISOPROPANOL,
BENZALKONIUM
CHLORIDE CLOTH
LARA KOZMETIK HIJYENIK URUNLERI SANAYI VE DIS 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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LARAMED ANTIBACTERIAL ALCOHOL 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. Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (65%,
weight/weight (w/w)) in an
aqueous solution denatured according to Alcohol and Tobacco Tax and
Trade Bureau regulations in
27 CFR part 20.
b. Isopropanol 10%, (w/w)
c. Benzalkonium Chloride 0.05%, (w/w)
d. Glycerol
e. Tocopherol
f. 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)
Alcohol 65% w/w. Purpose: Antiseptic
Isopropanol 10% w/w. Purpose: Antiseptic
Benzalkonium chloride 0.05% w/w. Purpose: Antiseptic
PURPOS E
Antiseptic, Hand Sanitizer
US E
Hand Sanitizer to help reduce bacteria that potentially can cause
disease. For use when soap and water
are not available.
WARNINGS
For external use only. Flammable liquid and vapor.
DO NOT USE
in children less than 2 months of age
on open skin wounds
When using this product do not use in or near eyes. In case of contact
with eyes, rinse eyes thoroughly
with water.
Stop use and ask a doctor if irritation or rash occurs. These may be
signs of a serious condition.
Keep out of reach of chil