HAND GEL SANITIZER- alcohol gel

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Allied Pressroom Products

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 GEL SANITIZER- ALCOHOL GEL
ALLIED PRESSROOM PRODUCTS
_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 GEL ETHYL ALCOHOL SANITIZER
This is an ethanol based hand sanitizer manufactured following the CDC
recomendation of using an
alcohol concentration of more than 60 % v/v alcohol when soap and
water is not available.
It is manufactured by gelling a 70 % ethanol solution with the the
minimum of an acrylate polymer to
create a clear gel that is easy to apply and does not evaporate as
readiliy as the liquid versions to
provide sufficient dwell time to be effective.
The hand sanitizer is manufactured using only the following United
States Pharmacopoeia (USP) grade
ingredients in the preparation of the product::
a. Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (80%,
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 (1.00 % v/v)..
c. Polypropylene Glycol (1.2 % v/v)..
d. Acrylate Polymer (0.3% v/v).
e. Sterile distilled water or boiled cold water.
No other materials are used.
ACTIVE INGREDIENT(S)
Ethyl Alcohol 70% 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
sig