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| Product NDC Code | 81126-020 | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Drug Name | Borel antiseptic hand sanitizer |
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| Type | Brand | ||||||||
| Active Ingredients |
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| Route | TOPICAL | ||||||||
| Dosage Form | LIQUID | ||||||||
| RxCUI drug identifier | 1039339 | ||||||||
| Application Number | part333A | ||||||||
| Labeler Name | Eti Maden Isletmeleri Genel Mudurlugu | ||||||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient Ethyl alcohol 80% w/w
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.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
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients aloe vera ( Aloe barbadensis ) extract, boric acid, disodium tetraborate decahydrate, glycerin, lavender ( Lavandula angustifolia ) oil, tea tree ( Melaleuca alternifolia ) oil, water
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.Uses • hand sanitizer to decrease bacteria on the skin • recommended for repeated use • for use when soap and water are not available
Purpose
Information about the drug product’s indications for use.Purpose Antiseptic
Spl product data elements
Usually a list of ingredients in a drug product.BOREL ANTISEPTIC HAND SANITIZER Ethyl alcohol ALCOHOL ALCOHOL ALOE VERA LEAF BORIC ACID SODIUM BORATE GLYCERIN LAVENDER OIL TEA TREE OIL WATER
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.Packaging Eti Maden-020
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.Drug Facts
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
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions? +1-833-267-3500 You may also report serious side effects to this phone number. Mon-Fri 9:00 AM - 5:00 PM
Storage and handling
Information about safe storage and handling of the drug product.Other information • store between 15-25˚C (59-86˚F) • avoid freezing and excessive heat above 40˚C (104˚F)
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.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.
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API