HAND SANITIZER- ethyl alcohol gel

País: Estados Unidos

Idioma: inglés

Fuente: NLM (National Library of Medicine)

Ingredientes activos:

ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)

Disponible desde:

Hans Manufacturer Inc.

Vía de administración:

TOPICAL

tipo de receta:

OTC DRUG

indicaciones terapéuticas:

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.

Estado de Autorización:

OTC monograph not final

Ficha técnica

HAND SANITIZER- ETHYL ALCOHOL GEL
HANS MANUFACTURER INC.
_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 - GEL75
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
ingredients in the
preparation of the product (percentage in final product formulation):
a. Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (75%,
volume/volume
(v/v)) in an aqueous solution denatured according to Alcohol and
Tobacco Tax and
Trade Bureau regulations in 27 CFR part 20.
b. Glycerol (0.5% v/v).
c. Carbomer (0.3% v/v).
d. Triethanolamine (0.3% v/v).
e. Aloe Barbadensis Leaf Extract (0.2% v/v)
f. Sterile distilled water or boiled cold water.
The firm does not add other active or inactive ingredients.
ACTIVE INGREDIENT(S)
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 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