BOREL ANTISEPTIC HAND SANITIZER- ethyl alcohol liquid 
Eti Maden Isletmeleri Genel Mudurlugu

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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ETiMADEN BOREL ANTISEPTIC HAND SANITIZER LIQUID

Drug Facts

Active ingredient

Ethyl alcohol 80% w/w

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

Flammable, keep away from fire/flame
For external use only

Do not use
• in children under three (3) years old
• on open skin wounds

When using this product • do not get into eyes. In case of contact, rinse eyes thoroughly with water

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

• store between 15-25˚C (59-86˚F)
• avoid freezing and excessive heat above 40˚C (104˚F)

Inactive ingredients

aloe vera (Aloe barbadensis) extract, boric acid, disodium tetraborate decahydrate, glycerin, lavender (Lavandula angustifolia) oil, tea tree (Melaleuca alternifolia) oil, water

Questions?

+1-833-267-3500
You may also report serious side effects to this phone number.

Mon-Fri 9:00 AM - 5:00 PM

ANTI BACTERIAL

ALCOHOL 80%

With Aloe Vera Extract

Manufactured for: ETI MADEN ISLETMELERI GENEL MUDURLUGU,
Kizilirmak Mahallesi 1443. Cadde No:5 06530 Cukurambar-Cankaya/ANKARA
TURKEY 06530   
Country of origin : TURKEY

Ministry of Health License Date and Number: 06/10/2020 – 2020/7

The shelf life of the product whose package cover is not opened is 2 years at room temperature. Use the product with opened packaging within 6 months.

BEFORE USING READ THE LABEL AND THE PROSPECTUS
KEEP AWAY FROM CHILDREN, FOOD AND FEEDS
DO NOT EAT ANYTHING DURING USE. DO NOT DRINK, DO NOT SMOKE.

Developed by BOREN Laboratories.

FOLLOW USAGE INSTRUCTION TO AVOID RISKS ON HUMAN AND ENVIRONMENTAL HEALTH

Empty packaging disposal method: Destroyed with the scope of National Legislation

Packaging

Eti Maden-020

BOREL ANTISEPTIC HAND SANITIZER 
ethyl alcohol liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81126-020
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL80 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
BORIC ACID (UNII: R57ZHV85D4)  
SODIUM BORATE (UNII: 91MBZ8H3QO)  
GLYCERIN (UNII: PDC6A3C0OX)  
LAVENDER OIL (UNII: ZBP1YXW0H8)  
TEA TREE OIL (UNII: VIF565UC2G)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:81126-020-01100 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product12/20/2020
2NDC:81126-020-021000 mL in 1 BOTTLE; Type 0: Not a Combination Product12/20/2020
3NDC:81126-020-035000 mL in 1 JUG; Type 0: Not a Combination Product12/20/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A12/20/2020
Labeler - Eti Maden Isletmeleri Genel Mudurlugu (552251787)

Revised: 12/2022
Document Id: a7fbba98-d780-47eb-8e77-fe782ddeeaf2
Set id: af6dc24d-8508-4f13-8d77-bd21a53e43fd
Version: 3
Effective Time: 20221219
 
Eti Maden Isletmeleri Genel Mudurlugu