Label: BOREL ANTISEPTIC HAND SANITIZER- ethyl alcohol liquid
- NDC Code(s): 81126-020-01, 81126-020-02, 81126-020-03
- Packager: Eti Maden Isletmeleri Genel Mudurlugu
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Drug Label Information
Updated December 19, 2022
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- Drug Facts
- Active ingredient
- Purpose
- Uses
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Warnings
Flammable, keep away from fire/flame
For external use onlyDo not use
• in children under three (3) years old
• on open skin woundsWhen 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 - Directions
- Other information
- Inactive ingredients
- Questions?
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SPL UNCLASSIFIED SECTION
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 : TURKEYMinistry 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
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INGREDIENTS AND APPEARANCE
BOREL ANTISEPTIC HAND SANITIZER
ethyl alcohol liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:81126-020 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 80 g in 100 mL Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:81126-020-01 100 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product 12/20/2020 2 NDC:81126-020-02 1000 mL in 1 BOTTLE; Type 0: Not a Combination Product 12/20/2020 3 NDC:81126-020-03 5000 mL in 1 JUG; Type 0: Not a Combination Product 12/20/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 12/20/2020 Labeler - Eti Maden Isletmeleri Genel Mudurlugu (552251787)
