ISOPROPYL ALCOHOL ANTISEPTIC 75% TOPICAL SOLUTION- isopropyl alcohol solution

Država: Združene države Amerike

Jezik: angleščina

Source: NLM (National Library of Medicine)

Aktivna sestavina:

ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302)

Dostopno od:

AV Coatings Ltd.

Pot uporabe:

TOPICAL

Tip zastaranja:

OTC DRUG

Terapevtske indikacije:

Antiseptic 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.

Status dovoljenje:

OTC monograph not final

Lastnosti izdelka

ISOPROPYL ALCOHOL ANTISEPTIC 75% TOPICAL SOLUTION- ISOPROPYL
ALCOHOL SOLUTION
AV COATINGS LTD.
_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._
----------
ISOPROPYL ALCOHOL ANTISEPTIC 75% TOPICAL SOLUTION
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. Isopropyl Alcohol (75%, v/v) in an aqueous solution denatured
according to Alcohol
and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
b. Glycerol (1.45% v/v).
c. Hydrogen peroxide (0.125% v/v).
d. 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)
Isopropyl Alcohol 75% v/v
PURPOSE
Antiseptic
USE
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. Keep away from heat or flame
DO NOT USE
in children less than 2 months of age
on open skin wounds
When using this product keep out of eyes, ears, and mouth. 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 children. If swallowed, get medical help or
contact a Poison Control
Center right away.
DIRECTIONS
Place enough product on hands to cover all surfaces. Rub hands
together until dry.
Supervise children under 6 years of age when using this pr