HAND SANITIZER-GEL- dial professional gel hand sanitizer gel 
Zotos International 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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Drug Facts

Active Ingredient(s)

Ethyl Alcohol 62% v/v. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

Use

Hand Sanitizer to help reduce bacteria that potentially can cause disease.

Warnings

For external use only. Flammable. Keep away from fire or flame

When using this product keep avoid contact with face, eyes, and broken skin. if eye contact occurs, flush thoroughly with water and seek medical advice.

Stop use and ask a doctor if irritation or redness develops.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Wet hands thoroughly with product and rub into skin until dry.

Children under 6 years of age should be supervised by an adult when using this product.

Inactive ingredients

Aqua (Water, Eau)• Propylene Glycol• Glycerin• Carbomer • Aminomethyl Propane! • lsopropyl Myrlstate • T-Butyl Alcohol

Questions

? 1-877-777-3277

Legal entity

®,TM,©2018 Distributed by
Henkel Corporation,
Rocky Hill, CT 06067
www.dialprofessional.com

Package Label - Principal Display Panel

Gel AWsanit 7.5Sanitizer 16Sanit 443Sanitizer 800

HAND SANITIZER-GEL 
dial professional gel hand sanitizer gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50663-003
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL60.146532 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX) 0.4985 mL  in 100 mL
WATER (UNII: 059QF0KO0R) 38.191 mL  in 100 mL
Propylene Glycol (UNII: 6DC9Q167V3) 0.5 mL  in 100 mL
AMINOMETHYLPROPANOL (UNII: LU49E6626Q) 0.14725 mL  in 100 mL
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC) 0.297 mL  in 100 mL
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) 0.147 mL  in 100 mL
TERT-BUTYL ALCOHOL (UNII: MD83SFE959) 0.072264 mL  in 100 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50663-003-01118 mL in 1 BOTTLE; Type 0: Not a Combination Product05/01/2020
2NDC:50663-003-02221 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product05/01/2020
3NDC:50663-003-03443 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product05/01/2020
4NDC:50663-003-04473 mL in 1 CELLO PACK; Type 0: Not a Combination Product05/01/2020
5NDC:50663-003-05800 mL in 1 CELLO PACK; Type 0: Not a Combination Product05/01/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35605/01/2020
Labeler - Zotos International Inc (966706145)

Revised: 4/2020
Document Id: a44cec41-bb92-811f-e053-2a95a90a1885
Set id: a44cf10f-c72d-811d-e053-2a95a90a0d6f
Version: 1
Effective Time: 20200427
 
Zotos International Inc