HANDERA INSTANT HAND SANITIZER- ethyl alcohol solution

Handera Instant Hand Sanitizer by

Drug Labeling and Warnings

Handera Instant Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Endeks Kimya Sanayi Ve Ticaret Anonim Sirketi. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

• 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 below 110F (43C)
• May discolor fabrics or surfaces

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.

SPL UNCLASSIFIED SECTION

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

INGREDIENTS AND APPEARANCE

HANDERA INSTANT HAND SANITIZER 
ethyl alcohol solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 78089-027
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
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 78089-027-01	100 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/25/2020
2	NDC: 78089-027-02	236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/25/2020
3	NDC: 78089-027-03	500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/25/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	06/25/2020

Labeler - Endeks Kimya Sanayi Ve Ticaret Anonim Sirketi (565678914)

Establishment
Name	Address	ID/FEI	Business Operations
Endeks Kimya Sanayi Ve Ticaret Anonim Sirketi		565678914	manufacture(78089-027)