QUICLEAN- hand sanitizer gel gel 
SIRIUS KOZMETIK SANAYI VE TICARET ANONIM SIRKETI

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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SIRIUS-GEL

Active Ingredient(s)

Alcohol 70% v/v

Purpose

Antimicrobial

Use

Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Warnings

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

Not edible, don't drink. Do not use in ears or mouth.

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.
Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

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

Directions

Put enough product in your palm to cover hands and rub hands together briskly until dry.

Children under 6 years age should be supervised when using QUICLEAN.

Other information

Inactive ingredients

Water (Aqua), Glycerin, Aminomethyl Propanol, Carbomer, Perfume (Bitter Orange oil)

Package Label - Principal Display Panel

59 mL NDC: 77222-222-01

59 mL NDC: 77222-222-01

QUICLEAN 
hand sanitizer gel gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77222-222
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
BITTER ORANGE OIL (UNII: 9TLV70SV6I)  
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
GLYCERIN (UNII: PDC6A3C0OX)  
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:77222-222-0159 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
2NDC:77222-222-02100 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
3NDC:77222-222-03250 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
4NDC:77222-222-04500 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A03/30/2020
Labeler - SIRIUS KOZMETIK SANAYI VE TICARET ANONIM SIRKETI (520078677)
Establishment
NameAddressID/FEIBusiness Operations
SIRIUS KOZMETIK SANAYI VE TICARET ANONIM SIRKETI520078677manufacture(77222-222)

Revised: 7/2020
Document Id: aa054e3b-6080-4bf8-e053-2995a90aa75a
Set id: a4fe4a81-6c44-dc2e-e053-2995a90a616c
Version: 3
Effective Time: 20200709
 
SIRIUS KOZMETIK SANAYI VE TICARET ANONIM SIRKETI