HAND SANITIZER- isopropyl alcohol gel

Χώρα: Ηνωμένες Πολιτείες

Γλώσσα: Αγγλικά

Πηγή: NLM (National Library of Medicine)

Δραστική ουσία:

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

Διαθέσιμο από:

Consolidated Chemicals, LLC

Οδός χορήγησης:

TOPICAL

Τρόπος διάθεσης:

OTC DRUG

Θεραπευτικές ενδείξεις:

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.

Καθεστώς αδειοδότησης:

OTC monograph not final

Αρχείο Π.Χ.Π.

HAND SANITIZER- ISOPROPYL ALCOHOL GEL
CONSOLIDATED CHEMICALS, LLC
_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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HAND SANITIZER GEL
HAND SANITIZER GEL
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. An inactive ingredient
(Hydroxypropyl
methylcellulose) has been added to increase the viscosity of hand
sanitizer.
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 and addition of hydroxypropyl Methylcellulose
(inactive ingredient
added to increase product viscosity):
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.
e. Hydroxypropyl Methylcellulose USP (0.5% w/v)
ACTIVE INGREDIENT(S)
Isopropyl Alcohol 75% v/v. Purpose: Antiseptic
PURPOSE
Antiseptic, Hand Sanitizer
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.
Stop use and ask a doctor if irritat