MEDILIVE- ethyl alcohol gel

MediLive by

Drug Labeling and Warnings

MediLive 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 Ingredient

Ethyl Alcohol 70%

Purpose

Antiseptic

Uses

Hand Sanitizer to decrease bacteria on the skin Recommended for repeated use 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
• in children less than 2 months of age.

Stop use and ask a doctor if

• irritation and redness develop
• condition persists for more than 72 hours

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 allow to dry without wiping
• Supervise children under 6 years of age when using this product to avoid swallowing

Other Information

• Do not store in direct sunlight
• Store below 50°C / 105°F
• Avoid freezing and excessive heat above 40°C (104°F)

INACTIVE INGREDIENT

Inactive Ingredients: water, glycerin, carbomer, triethanolamine, parfum, tocopheryl acetate, aloe barbadensis leaf juice, benzylsalicylate, linalool, limonene, hydroxycitronellal, coumarin.

QUESTIONS

Questions : export@endekskimya.com

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

SPL UNCLASSIFIED SECTION

No rinsing

%70 ALCOHOL

Uretici / Manufacturer

Ishlab chiqaruvchi /

endeks

Kimya San. ve Tic A.S.

Adnan Kahveci Mahallesi, Davutpasa Cad.No:17

Beylikdüzü / ISTANBUL Tel: +90 212 856 13 66

info@endekskimya.com export@endekskimya.com

Icerik veri belgesinin edinilebilecegi adres:

www.endekskmya.com

Packaging

INGREDIENTS AND APPEARANCE

MEDILIVE 
ethyl alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 78089-026
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)
BENZYL SALICYLATE (UNII: WAO5MNK9TU)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR)
COUMARIN (UNII: A4VZ22K1WT)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 78089-026-01	100 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/02/2020
2	NDC: 78089-026-02	236 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/02/2020
3	NDC: 78089-026-03	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/02/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	06/02/2020

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(78089-026)