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Ethanol - Medication Information

Product NDC Code 53125-803
Drug Name

Ethanol

Type Brand
Active Ingredients
Alcohol .7 ml/ml
Route TOPICAL
Dosage Form SOAP
Application Number 505G(a)(3)
Labeler Name Superior Chemical Co DBA NorthWoods
Packages
Package NDC Code Description
53125-803-88 500 ml in 1 bottle, plastic (53125-803-88)
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active ingredient Ethyl Alcohol 70% 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 for usage and dosage Read entire label before using this product Place enough product on your palm to thoroughly cover your hands. Rub hands together briskly until dry

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
inactive ingredients Aloe Barbadensis Leaf Juide, D&C Green #5, Fragrance, PER-10 Acrylate/perfluorohexylethly Acrylate copolymer, Perfluoroheexylethyl alcohol, propylene glycol, 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.
indications and usage 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.
purpose Antiseptic

Spl product data elements

Usually a list of ingredients in a drug product.
ethanol Derma Foam Excel Hand Sanitizer HYDROXYCITRONELLAL D&C GREEN NO. 5 2-SEC-BUTYL CYCLOHEXANONE WATER ALCOHOL ALCOHOL 4-CYCLOHEXYL-2-METHYL-2-BUTANOL ALOE VERA LEAF HEXYL ACETATE TETRAHYDROLINALOOL ISOPROPYLPHENYLBUTANAL 2-(PERFLUOROHEXYL)ETHANETHIOL PEG-10 ACRYLATE/PERFLUOROHEXYLETHYL ACRYLATE COPOLYMER PROPYLENE GLYCOL

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.
principle label product label

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 wording Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

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 directions when using this product avoid contact with eyes. if contact occurs, rinsth thoroughly wiht water. Stop use and ask a doctor if irriataion or rash occurs

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.
Warning statement Fore external use only. FLAMMABLE. This product contains ethyl alcohol. 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