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| Product NDC Code | 78060-001 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | Hypex antibacterial hand sanitizer |
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| Type | Brand | ||||||
| Active Ingredients |
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| Route | TOPICAL | ||||||
| Dosage Form | GEL | ||||||
| Application Number | part333A | ||||||
| Labeler Name | Jordan Chemical Industries Co. LTD | ||||||
| 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(s) Ethanol 70% v/v. Purpose: Antiseptic
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 Apply a suitable amount of this product on your hands, rub hands together until dry without wiping. For children under 6 years old, use only with adult supervision Store at room tempreture.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients glycerin, hydrogen peroxide, water, triethanolamine, Vitamin E (lipobeads) , Carbomer
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.Use * To decrease bacteria on skin that could cause diseases * recommended for repeated use
Purpose
Information about the drug product’s indications for use.Purpose Antiseptic, Hand Sanitizer
Spl product data elements
Usually a list of ingredients in a drug product.Hypex Antibacterial Hand Sanitizer ALCOHOL GLYCERIN CUPRIC BIS(TRIETHANOLAMINE) WATER ALCOHOL ALCOHOL ALPHA-TOCOPHEROL HYDROGEN PEROXIDE CARBOMER 940
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.Package Label - Principal Display Panel 110ml NDC: 78060-001-02 500ml bottle 110 ml bottle label label
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.This is a hand sanitizer manufactured according to the Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (CoViD-19); Guidance for Industry . The hand sanitizer is manufactured using only the following United States Pharmacopoeia (USP) grade ingredients in the preparation of the product (percentage in final product formulation) consistent with World Health Organization (WHO) recommendations: Ethanol 70% Triethanolamine 0.34ml water Hydrogen Peroxide 0.125 alpha-tocopherol 0.0003 carbomer 940 0.36 Glycerin 1.45 ml
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 irritation occurs or swallowed, seek medical help
Stop use
Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.Stop use and ask a doctor if irritation or rash occurs.
When using
Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.When using this product keep * Keep out of eyes. In case of contact with eyes, flush thoroughly with water * do not inhale or ingest *avoid contact with broken skin
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 For external use only: hands Flammable, keep away from heat or flame
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