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Anti-bacterial hand cleanser - Medication Information

Product NDC Code 49852-301
Drug Name

Anti-bacterial hand cleanser

Type Brand
Active Ingredients
Alcohol 62 g/100ml
Route TOPICAL
Dosage Form LIQUID
Application Number part333A
Labeler Name Tri-Coastal Design Company Inc.
Packages
Package NDC Code Description
49852-301-30 30 ml in 1 bottle, plastic (49852-301-30)
49852-301-45 45 ml in 1 bottle, plastic (49852-301-45)
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active Ingredient Ethyl Alcohol 62%

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 (Aqua), Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Triethanolamine, Fragrance (Parfum), PEG-40 Hydrogenated Castor Oil, Jojoba Esters, Red 4, Red 33

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 For handwashing to decrease bacteria on the skin Recommended for repeated use

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.
anti-bacterial Hand Cleanser Ethyl Alcohol WATER CARBOMER INTERPOLYMER TYPE A (55000 CPS) TROLAMINE POLYOXYL 40 HYDROGENATED CASTOR OIL HYDROLYZED JOJOBA ESTERS (ACID FORM) FD&C RED NO. 4 D&C RED NO. 33 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 Label image description

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.
Other information Store below 105F 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.

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 If 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 membrane contact; rinse area thoroughly with water Use only as directed

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 disturbances

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