Simoniz Hand Sanitizer Gel

Simoniz Hand Sanitizing by

Drug Labeling and Warnings

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

Drug Details [pdf]

SIMONIZ HAND SANITIZING- alcohol gel 
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 Hand Sanitizer Gel

Drug Facts

Active Ingredient

Ethyl Alcohol 70% v/v

Purpose

Antiseptic

Uses

• To decrease bacteria on the skin that potentially can cause disease.
• Recommended for repeated use.

Warnings

• Flammable, keep away from heat or flame.
• For external use only.

Keep out of eyes, ears or mouth. In case of eye contact, flush with water.

Stop use and ask a doctor if irritation and redness develop or if condition persists more than 72 hours.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. Children should be supervised by an adult when using this product.

Directions

• Apply sufficient amount of product to your palm to cover both hands.
• Rub until dry.

Other Information May discolor certain fabrics and surfaces.

Inactive ingredients Acrylates/C 10/30 Alkyl Acrylate Crosspolymer, PEG/PPG-18/18 Dimethicone, Triethanolamine, Vitamin E, Water

Questions?

Call: 1-800-227-5536 or visit our website: www.simonizjanitorial.com

SIMONIZ

SIMONIZ USA, INC.

201 Boston Tpke.

Bolton, CT 06043

SIMONIZ

instant waterless

ALCOHOL HAND SANITIZING GEL

with Vitamin E

Dries quickly, leaves skin feeling soothed and moisturized

KILLS 99.99% OF GERMS

8 oz

SIMONIZ HAND SANITIZING 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63900-004
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
ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)
TROLAMINE (UNII: 9O3K93S3TK)
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63900-004-08	237 mL in 1 BOTTLE; Type 0: Not a Combination Product	02/13/2021	06/13/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	02/13/2021	06/13/2022

Labeler - Simoniz, USA, Inc. (058510272)

Revised: 1/2023

Document Id: f306c7f6-7599-366f-e053-2a95a90a4dd0

34390-5

Set id: bb3e2655-0fb8-a422-e053-2a95a90a99aa

Version: 2

Effective Time: 20230124