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Hand sanitizer - Medication Information

Product NDC Code 56194-503
Drug Name

Hand sanitizer

Type Brand
Active Ingredients
Alcohol 65 ml/100ml
Route TOPICAL
Dosage Form GEL
RxCUI drug identifier 902574
Application Number part333A
Labeler Name Giant Eagle
Packages
Package NDC Code Description
56194-503-01 30 ml in 1 bottle, plastic (56194-503-01)
56194-503-02 59 ml in 1 bottle, plastic (56194-503-02)
56194-503-03 236 ml in 1 bottle, plastic (56194-503-03)
56194-503-04 946 ml in 1 bottle, plastic (56194-503-04)
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active Ingredient Ethyl Alcohol 65%

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 occasional and personal use. Rub thoroughly into hands for at least 30 seconds. Allow to dry. Children under 6 years should be supervised when using this product.

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Inactive ingredients Water (Aqua), PEG-6, Fragrance, (Parfum), Isopropyl Alcohol, Glycerin, Isopropyl Myristate, Aloe Barbadensis Leaf Juice, Tocopheryl Acetate, AMP-Acrylates/Vinyl Isodecanate Crosspolymer.

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 personal hand hygiene to help prevent the spread of bacteria, and can be used in place of hand washing if 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 ALCOHOL FRAGRANCE CLEAN ORC0600327 ISOPROPYL ALCOHOL ALOE VERA LEAF .ALPHA.-TOCOPHEROL ACETATE ACRYLATES/VINYL ISODECANOATE CROSSPOLYMER (10000 MPA.S NEUTRALIZED AT 0.5%) GLYCERIN POLYETHYLENE GLYCOL, UNSPECIFIED WATER ISOPROPYL MYRISTATE 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 - Principal Display Panel Hand Sanitizer 1oz Package Label - Principal Display Panel Hand Sanitizer 2oz Package Label - Principal Display Panel Hand Sanitizer with Pump 8oz Pavkage Label - Principal Display Panel Hand Sanitizer with Pump 32oz

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 Do not use On children less than 2 months of age On open skin wounds On broken or damaged skin.

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 Keep out of reach of children. In case of accidental ingestion, get medical help or contact a 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 or comments? 1-866-695-3030

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 Stop use and ask a doctor If irritation or redness develops and lasts.

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 When using this product avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water. Do not inhale.

Storage and handling

Information about safe storage and handling of the drug product.
Other information Store at a temperature below 110ºF (43ºC). May discolor certain fabrics or surfaces.

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 source of heat or fire. When using this product When using this product avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water. Do not inhale. Do not use Do not use On children less than 2 months of age On open skin wounds On broken or damaged skin. Stop use and ask a doctor Stop use and ask a doctor If irritation or redness develops and lasts. Keep out of reach of children Keep out of reach of children. In case of accidental ingestion, get medical help or contact 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