HANDERA INSTANT HAND SANITIZER- ethyl alcohol solution 
Endeks Kimya 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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Handera Instant Hand Sanitizer

Drug Facts

Active Ingredients

 Ethyl Alcohol 70% v/v

Purpose

Antiseptic

Uses:

Hand sanitizer to help bacteria on the skin.

For use when soap and water are not available.

Warnings

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

Do Not use

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

Other information

Inactive ingredients

Water, Glycerin, Carbomer, Perfume, Triethanolamine, Tocopheryl Acetate, Aloe Barbadensis Leaf Juice

Questions

P: +1 703 343 67 67

Mon -Fri 9:00 AM-5:00 PM You may also report serious side effects to this phone number.

Moisturizing with vitamin E and Aloe

KILLS 99% OF VIRUSES & GERMS

Distributed by:

Asena's Group LLC 22102 VA

www.asenasgroup.com

info@asenasgroup.com

Made in TURKEY

Packaging

untitled

HANDERA INSTANT HAND SANITIZER 
ethyl alcohol solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78089-027
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
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
TROLAMINE (UNII: 9O3K93S3TK)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:78089-027-01100 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/25/2020
2NDC:78089-027-02236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/25/2020
3NDC:78089-027-03500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/25/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A06/25/2020
Labeler - Endeks Kimya Sanayi Ve Ticaret Anonim Sirketi (565678914)
Establishment
NameAddressID/FEIBusiness Operations
Endeks Kimya Sanayi Ve Ticaret Anonim Sirketi565678914manufacture(78089-027)

Revised: 6/2020
Document Id: 278ccaec-b9d7-4d4b-aded-6ce8c92fbf05
Set id: 16f55913-cc0a-46b5-b0fd-7b23d7239dee
Version: 1
Effective Time: 20200625
 
Endeks Kimya Sanayi Ve Ticaret Anonim Sirketi