HAND SANITIZER- alcohol aerosol, spray

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 develops and lasts.

Authorization status:

OTC monograph not final

Summary of Product characteristics

HAND SANITIZER- ALCOHOL AEROSOL, SPRAY
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._
----------
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
c. Sterile distilled water or boiled cold water.
.
ACTIVE INGREDIENT(S)
Alcohol 78% v/v. Purpose: Antiseptic
PURPOS E
Antiseptic, Hand Sanitizer
US E
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 develops and lasts.
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 develops and lasts.
Keep out of reach of children. If swallowed, get medical help or
contact a Poison Control Center right
away.
DIRECTIONS
Spray enough product on hands to cover all surfaces. Rub hands
together until dry.
For children under 6, use only under adult supervision.
OTHER INFORMATION
Store between 15-30C (59-86F)
Avoid freezing and excessive heat above 40C (104F)
INACTIVE INGREDIENTS
glycerin, water
PACKAGE LABEL - PRINCIPAL DISPLAY PANEL
66 mL NDC: 72686-183-10
fridababy_2oz_BOV.jpg
HAND SANITIZER
alcohol aerosol, spray
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN OTC DRUG
ITE M CODE (SOURCE )
NDC:726 8 6 -18 3
ROUTE OF ADMINISTRATION
TOPICAL
ACTIVE INGREDIENT/ACTIVE MOIETY
Fareva Morton Grove, Inc.
INGREDIENT NAME
BASIS OF STRENGTH
STRE NG TH
ALCO HO L (UNII: 3K9 9 58 V9 0 M) (AL