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| Product NDC Code | 78434-110 | ||||||||||||||||||||||||
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| Drug Name | Accurate labs 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 | Accurate Labs, LLC | ||||||||||||||||||||||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient Ethyl alcohol 80% v/v
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 d-limonene, glycerin, 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.ACCURATE LABS ANTISEPTIC HAND SANITIZER Ethyl alcohol ALCOHOL ALCOHOL LIMONENE, (+)- GLYCERIN 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 untitled
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
Alcohol Antiseptic 80% Topical Solution Non-Sterile Solution Manufactured for: Accurate Labs, LLC 301W 50th St, Odessa, TX 79764
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? 1-800-484-1699 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 20-25°C (68-77°F) • avoid freezing and excessive heat above 40°C (104°F) • may discolor certain fabrics
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 less than 2 months of age • 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