Simoniz Foaming Alcohol Hand Sanitizer

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]

SIMONIZ FOAMING ALCOHOL HAND SANITIZER- alcohol liquid 
Simoniz USA, 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.

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Simoniz Foaming Alcohol Hand Sanitizer

Drug Facts

Active ingredient

Ethyl Alcohol 70% (v/v)

Purpose

Antiseptic

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

• 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

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

Simonize USA inc.

201 Boston Turnpike, Bolton, CT 06043

800-227-5536

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	10/08/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	02/13/2021	10/08/2022

Labeler - Simoniz USA, Inc (058510272)

Revised: 1/2023

Document Id: f306cff8-5946-427c-e053-2a95a90a356d

34390-5

Set id: bb3da450-1943-fc5f-e053-2a95a90a9e79

Version: 2

Effective Time: 20230124