HAND SANITIZER- alcohol gel

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Fareva Morton Grove, Inc.

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

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.

Authorization status:

OTC monograph not final

Summary of Product characteristics

HAND SANITIZER- ALCOHOL GEL
FAREVA MORTON GROVE, 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 GEL ZESTY CITRUS
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.
a. Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (77%,
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. WATER (AQUA)
c. GLYCERIN
d. FRAGRANCE (PARFUM)
e. ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER
f. MANNITOL
g. ALOE BARBADENSIS LEAF JUICE
h. AMINOMETHYL PROPANOL
i. MICROCRYSTALLINE CELLULOSE
j. TOCOPHERYL ACETATE
k. IRON OXIDES (CI 77492)
l. HYDROXYPROPYL METHYLCELLULOSE
m. CITRIC ACID
n. SODIUM BENZOATE
o. POTASSIUM SORBATE
ACTIVE INGREDIENT(S)
Alcohol 77% v/v. Purpose: Antiseptic
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 and redness develops and
persists.
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 surfaces. Rub hands
together until dry.
Supervise children under 6 years of age when