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| Product NDC Code | 78587-000 | ||||
|---|---|---|---|---|---|
| Drug Name | Omni fresh by facela hand sanitizer |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | GEL | ||||
| RxCUI drug identifier | 1305100 | ||||
| Application Number | 505G(a)(3) | ||||
| Labeler Name | Industrias Facela SA de CV | ||||
| 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 75% 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: Read the entire label before using this product. Dispense 2 pumps of produc onto palm of hand and rub thoroughly over all surfaces of both hands until dry.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients: Water, Tetrahydroxypropyl Ethylenediamine, Carbomer, Fragrance
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 reduce microorganisms on the skin. Use this product when soap and water are not available.
Purpose
Information about the drug product’s indications for use.Antiseptic
Spl product data elements
Usually a list of ingredients in a drug product.Omni Fresh by Facela Hand Sanitizer ALCOHOL WATER EDETOL CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE ALCOHOL ALCOHOL
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 Labeling: Bottle
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
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.
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. Avoid contact with eyes. If contact occurs, rinse thoroughly with water. Flammable. This product contains ethyl alcohol. Keep away from source of ignition. Discontinue use if irritation or redness develops. If irritation persists for more than 72 hours, consult a physician. 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