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Hand sanitizer - Medication Information

Product NDC Code 74979-002
Drug Name

Hand sanitizer

Type Brand
Active Ingredients
Alcohol .75 ml/ml
Route TOPICAL
Dosage Form LIQUID
RxCUI drug identifier 1047755
Application Number 505G(a)(3)
Labeler Name Robert Gordon Ind. Ltd.
Packages
Package NDC Code Description
74979-002-10 100 ml in 1 bottle (74979-002-10)
74979-002-25 250 ml in 1 bottle (74979-002-25)
74979-002-50 500 ml in 1 bottle (74979-002-50)
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active ingredient Alcohol 75 % 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 Rub dime sized amount between hands until dry. Supervise children in the use of this product. In the case of eye contact, rinse eyes thoroughly with water.

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Inactive ingredients Water,Glycerin, Propylene Glycol, Carbomer, Aminomethyl Propanol.

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 For handwashing to decrease bacteria on the skin

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.
Hand Sanitizer ALCOHOL WATER GLYCERIN PROPYLENE GLYCOL CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE AMINOMETHYLPROPANOL 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: 100ml Bottle Package Labeling:250ml Bottle2 Package Labeling:500ml Bottle3

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 Store below 105 °F May discolor some fabrics.

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,contact a doctor or Poison Control Center immediately.

Questions

A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.
Questions? 516-354-8888

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 Condition worsens Redness or irritation develops Condition persists for more than 3 days

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 Avoid the eyes and mucous membranes In the case of eyes or mucous membranes contact, rinse area thoroughly with water

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 Flammable, keep away from fire and flame Does not contain grain alcohol; do not drink if taken internally will produce serious gastric distric disturbances. When using this product Avoid the eyes and mucous membranes In the case of eyes or mucous membranes contact, rinse area thoroughly with water Stop use and ask a doctor if Condition worsens Redness or irritation develops Condition persists for more than 3 days Keep out of reach of children If swallowed,contact a doctor or 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