SIMONIZ FOAMING ALCOHOL HAND SANITIZER- alcohol liquid

Simoniz Foaming Alcohol Hand Sanitizer by

Drug Labeling and Warnings

Simoniz Foaming Alcohol Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Simoniz USA, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredient

Ethyl Alcohol 70% (v/v)

PURPOSE

Purpose

Antiseptic

INDICATIONS & USAGE

Uses

For handwashing to decrease bacteria on the skin after changing diapers, after assisting ill persons or before contact with a person under medical care or treatment. Recommended for repeated use.

WARNINGS

Warnings

• For external use only. Keep out of eyes, ears or mouth.

• Discontinue use if irritation occurs

• Keep out of reach of children

FLAMMABLE. KEEP AWAY FROM FIRE OR FLAME

DOSAGE & ADMINISTRATION

Directions

• If hands are visibily soiled, wash with soap and water and dry hands.
• Wet hands thoroughly with product, especially the area under the fingernails and allow to dry without rinsing.

INACTIVE INGREDIENT

Inactive ingredients Benzalkonium chloride, chlorhexidine gluconate, isopropyl alcohol, PEG-10 dimethicone, PEG-14M, phenoxyethanol, polyquaternium-10, Water.

SPL UNCLASSIFIED SECTION

Simonize USA inc.

201 Boston Turnpike, Bolton, CT 06043

800-227-5536

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SIMONIZ FOAMING ALCOHOL HAND SANITIZER 
alcohol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63900-003
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	70 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E)
WATER (UNII: 059QF0KO0R)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
POLYQUATERNIUM-10 (1000 MPA.S AT 2%) (UNII: GMR4PEN8PK)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
PEG-14 1-((METHYLPHENYL)ETHYL)PHENYL ETHER AMMONIUM SULFATE (UNII: S4S9783N13)
PHENOXYETHANOL (UNII: HIE492ZZ3T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63900-003-40	3780 mL in 1 JUG; Type 0: Not a Combination Product	02/13/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	02/13/2021

Labeler - Simoniz USA, Inc (058510272)