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Antiseptic hand rub - Medication Information

Product NDC Code 39892-0412
Drug Name

Antiseptic hand rub

Type Brand
Active Ingredients
Alcohol 620 mg/ml
Route TOPICAL
Dosage Form GEL
RxCUI drug identifier 581660
Application Number 505G(a)(3)
Labeler Name Owens & Minor Distribution, Inc.
Packages
Package NDC Code Description
39892-0412-1 1.5 ml in 1 packet (39892-0412-1)
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active ingredient Alcohol denat. (anhydrous) 62% 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 to clean, dry hands Wet hands thoroughly with product and allow to dry

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Inactive ingredients Purified water, Carbomer 2020, PPG-20 methyl glucose ether, Carbomer 980, Diisopropanolamine, Fragrance (Lemon), FD&C blue No.1, FD&C yellow No.5

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 Instant hand antiseptic

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.
Antiseptic Hand Rub ALCOHOL WATER PPG-20 METHYL GLUCOSE ETHER DIISOPROPANOLAMINE LEMON FD&C BLUE NO. 1 FD&C YELLOW NO. 5 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: Label3

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 Other information Recommended for repeated use Reduces bacteria that can potentially cause disease

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. In case of accidental ingestion, seek professional assistance or consult a poison control center immediately.

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 significant irritation or sensitization 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.
Warnings Keep out of eyes. If contact with eyes occurs, rinse promptly and thoroughly with water. For external use only. Keep away from fire or flame. Flammable. Stop use and ask a doctor if significant irritation or sensitization occurs. Keep out of reach of children. In case of accidental ingestion, seek professional assistance or consult a poison control center immediately.

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