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 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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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)
a. Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (78%,
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. Glycerin (1.72% v/v).
c. Hydroxypropylcellulose (1.28% v/v).
d. Sterile distilled water or boiled cold water.
ACTIVE INGREDIENT(S)
Alcohol 78% v/v. 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. 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 surfaces. Rub hands
together until dry.
Supervise children under 6 years of age when using this product to
avoid swallowing.
OTHER INFORMATION
Store between 15-30C (59-86F)
Avoid freezing and excessive heat above 40C (104F)
INACTIVE INGREDIENTS
Water (Aqua), Glycerin, Hydroxypropylcellulose
PACKAGE LABEL - PRIN