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Hand sanitizer - Medication Information

Product NDC Code 74496-9751
Drug Name

Hand sanitizer

Type Brand
Active Ingredients
Alcohol 75 ml/100ml
Route TOPICAL
Dosage Form GEL
RxCUI drug identifier 1305100
Application Number part333A
Labeler Name Hans Manufacturer Inc.
Packages
Package NDC Code Description
74496-9751-1 30 ml in 1 bottle (74496-9751-1)
74496-9751-2 60 ml in 1 bottle (74496-9751-2)
74496-9751-3 100 ml in 1 bottle (74496-9751-3)
74496-9751-7 60 ml in 1 bottle (74496-9751-7)
74496-9751-8 240 ml in 1 bottle, pump (74496-9751-8)
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active Ingredient(s) Alcohol 75% v/v. 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 Place enough product on hands to cover all surfaces. Rub hands together until dry. Supervise children under 6 years of age when using this product to avoid swallowing.

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Inactive ingredients purified water USP, glycerin, carbomer, triethanolamine, aloe barbadensis leaf juice

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 Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Purpose

Information about the drug product’s indications for use.
Purpose Antiseptic, Hand Sanitizer

Spl product data elements

Usually a list of ingredients in a drug product.
Hand Sanitizer ETHYL ALCOHOL CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE GLYCERIN TROLAMINE WATER ALCOHOL ALCOHOL ALOE VERA LEAF

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 - Principal Display Panel 30 mL NDC: 74496-9751-1 60ml NDC: 74496-9751-2 100ml NDC: 74496-9751-3 60ml NDC: 74496-9751-7 240ml NDC: 74496-9751-8 30ml front 30ml back 60ml front 60ml back 100ml front 100ml back 60ml Hand Sanitizer with carabiner 240ml Hand Sanitizer Pump

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.
This is a hand sanitizer manufactured according to the Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (CoViD-19); Guidance for Industry . The hand sanitizer is manufactured using only the following ingredients in the preparation of the product (percentage in final product formulation): Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (75%, volume/volume (v/v)) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20. Glycerol (0.5% v/v). Carbomer (0.3% v/v). Triethanolamine (0.3% v/v). Aloe Barbadensis Leaf Extract (0.2% v/v) Sterile distilled water or boiled cold water. The firm does not add other active or inactive ingredients.

Do not use

Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.
Do not use in children less than 2 months of age on open skin wounds

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.

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 irritation or rash occurs. These may be signs of a serious condition.

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 keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water. Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Storage and handling

Information about safe storage and handling of the drug product.
Other information Store between 15-30C (59-86F) Avoid freezing and excessive heat above 40C (104F)

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 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