Ultra clean HAND SANITIZER ANTIBACTERIAL GEL

ULTRA CLEAN by

Drug Labeling and Warnings

ULTRA CLEAN by is a Otc medication manufactured, distributed, or labeled by GUNSU ENERJI SISTEMLERI VE KONFOR TESISLERI SANAYI VE TICARET ANONIM SIRKETI. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ULTRA CLEAN HAND SANITIZER- alcohol gel 
GUNSU ENERJI SISTEMLERI VE KONFOR TESISLERI 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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Ultra clean HAND SANITIZER ANTIBACTERIAL GEL

Drug Facts

Active ingredient(s)

Alcohol 70% v/v

Purpose

Antiseptic

Use(s):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

Do not use  * in children less than 2 months of age

                    * on open skin wounds

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.

Directions: *Place enough product on hands to cover all surfaces. Rub hands together until dry. *Supervise children under 6 years of age when using this product to avoid swallowing

Other information : * Store between 15-30 C (59 - 86 F)

*Avoid freezing and excessive heat above 40C (104F)

Inactive ingredients: Aminomethyl Propanol, Carbomer, Glycerin, Lemon Oil, Purified Water,

PLUS FORMULA

PROTECTION

Alcohol Antiseptic 70%

instant effect!

KILLS MOST OF THE ILLNESS CAUSING GERMS

Distributed by Civilon LLC 229 Crooks Ave Clifton, NJ 07011

MADE IN TURKEY

Production Date : 23.05.2020 | Lot Number : 1212

Lot Number : 1213

Packaging

ULTRA CLEAN  HAND SANITIZER
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 78099-102
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
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
GLYCERIN (UNII: PDC6A3C0OX)
LEMON OIL, COLD PRESSED (UNII: I9GRO824LL)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 78099-102-01	60 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/15/2020	04/06/2022
2	NDC: 78099-102-02	100 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/15/2020	04/06/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	04/15/2020	04/06/2022

Labeler - GUNSU ENERJI SISTEMLERI VE KONFOR TESISLERI SANAYI VE TICARET ANONIM SIRKETI (535289011)

Establishment
Name	Address	ID/FEI	Business Operations
GUNSU ENERJI SISTEMLERI VE KONFOR TESISLERI SANAYI VE TICARET ANONIM SIRKETI		535289011	manufacture(78099-102)

Revised: 1/2022

Document Id: f2be3d8c-ad4e-40cf-8548-f7e603318a79

34390-5

Set id: e54e7918-a7ef-469e-9962-645b10c9e583

Version: 2

Effective Time: 20220124

 

GUNSU ENERJI SISTEMLERI VE KONFOR TE