HAND SANITIZER- alcohol gel

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

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

Tilgjengelig fra:

Fareva Morton Grove, Inc.

Administreringsrute:

TOPICAL

Resept typen:

OTC DRUG

Indikasjoner:

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 and redness develops and persists.

Autorisasjon status:

OTC monograph not final

Preparatomtale

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._
----------
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. Glycerin
c. FRAGRANCE (PARFUM)
d. ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER
e. ALOE BARBADENSIS LEAF JUICE
f. AMINOMETHYL PROPANOL
g. RED 4 (CI 14700)
h. CITRIC ACID
i. SODIUM BENZOATE
j. POTASSIUM SORBATE
ACTIVE INGREDIENT(S)
Alcohol 78% v/v. Purpose: Antiseptic
PURPOS E
Antiseptic
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 and redness develops and
persists.
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
Acrylates/C10-30 Acrylate Crosspolymer, Aloe Barbadensis Leaf Juice,
Aminomethyl Propanol, Citric
Acid, Fragrance, Glycerin, Potassium Sorbate, Red 4 (CI 14700), Sodium
Benzoate, Water
PACKAGE LABEL - PRINCIPAL DISPLAY PANEL
50 mL NDC: 72686-188-05
HAND SANITIZER
alcohol gel
Fareva Morton Grove, Inc.
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN OTC DRUG
ITE M CODE (SOURCE )
NDC:726 8 6 -18 8
ROUTE OF ADMIN