SANILUXE HAND SANITIZER ALCOHOL FREE- benzalkonium chloride gel

SaniLuxe Hand Sanitizer Alcohol Free by

Drug Labeling and Warnings

SaniLuxe Hand Sanitizer Alcohol Free 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

Benzalkonium Chloride 0.1%

Purpose

Antimicrobial

Uses

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

Warnings

• For external use only.

• Keep out of reach of children.

• When using this product avoid contact with eyes. In case of eye contact, flush eyes with water.

• Stop use and ask a doctor if irritation or redness develops, or if condition persists for more than 72 hours.
• If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• Pump a small amount of gel into palm of hand
• Rub hands together briskly until dry
• Rub thoroughly over all surfaces of both hands

Inactive ingredients

Water (Aqua), Triethylene Glycol, Glycereth-26, Cocamidopropyl PG-Dimonium Cloride Phosphate,Hydroxyethylcellulose, DMDM Hydantoin, Triethanolamine, Fragrance (Aroma), Iodopropynyl Butyl Carbamate, 1, 3-Butanediol

PRINCIPAL DISPLAY PANEL - 284 ml Bottle Label

SaniLuxe™

HAND SANITIZER GEL

Alcohol free

• 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

SANILUXE HAND SANITIZER ALCOHOL FREE 
benzalkonium chloride gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71489-008
Route of Administration	CUTANEOUS

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	1 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
TRIETHYLENE GLYCOL (UNII: 3P5SU53360)
GLYCERETH-26 (UNII: NNE56F2N14)
COCAMIDOPROPYL PROPYLENE GLYCOL-DIMONIUM CHLORIDE PHOSPHATE (UNII: H2KVQ74JM4)
HYDROXYETHYL CELLULOSE (5000 MPA.S AT 1%) (UNII: X70SE62ZAR)
DMDM HYDANTOIN (UNII: BYR0546TOW)
TROLAMINE (UNII: 9O3K93S3TK)
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71489-008-01	284 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	02/19/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part333E	02/19/2019

Labeler - Celeste Industries Corporation (047795034)