SANI LUXE HAND SANITIZER WITH ALCOHOL- alcohol gel

Sani Luxe Hand Sanitizer with Alcohol by

Drug Labeling and Warnings

Sani Luxe Hand Sanitizer with Alcohol by is a Otc medication manufactured, distributed, or labeled by Celeste Industries Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Ethyl Alcohol 62.5%

Purpose

Antimicrobial

Uses

• Recommended for repeated use
• For hand sanitizing to decrease bacteria on the skin

Warnings

• For external use only.
• Flammable. Keep away from open flame and sources of heat.

• Stop use and ask a doctor if irritation or redness develops, or if condition persists for more than 72 hours.

• When using this product, avoid contact with eyes. In case of eye contact, flush eyes with water.
• If swallowed, get medical help or contact a Poison Control Center right away.

• Keep out of reach of children.

Directions

• Children under 6 years of age should be supervised when using this product
• Place enough product in your palm to thoroughly cover your hands
• Rub hands together briskly until dry

Other information

• Store below 110°F (43°C)
• May discolor certain fabrics or surfaces.

Inactive ingredients

Aqua, PEG-4 Diheptanoate, Acrylates/C10-30 Alkyl Acrylate crosspolymer, Fragrance, Aminomethyl Propanol

May contain hydroxypropylcellulose.

PRINCIPAL DISPLAY PANEL - 284 ml Bottle Label

Sani Luxe®
HAND SANITIZER GEL
with Alcohol

• Requires no water or towels.
• Apply small amount to hands
  and rub until dry.

Kills 99%
of germs
on contact

Caution: Use on hands only.

284ml e

INGREDIENTS AND APPEARANCE

SANI LUXE HAND SANITIZER WITH ALCOHOL 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71489-007
Route of Administration	CUTANEOUS

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	0.625 mL  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
PEG-4 DIHEPTANOATE (UNII: 2DQ7O61VHJ)
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71489-007-01	284 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	01/24/2019
2	NDC: 71489-007-02	177 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	03/25/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	01/24/2019

Labeler - Celeste Industries Corporation (047795034)