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Antibacterial hand sanitizer - Medication Information

Product NDC Code 70204-513
Drug Name

Antibacterial hand sanitizer

Type Brand
Active Ingredients
Alcohol 62 ml/100ml
Route TOPICAL
Dosage Form GEL
RxCUI drug identifier 581660
Application Number part333A
Labeler Name Hit Promotional Products, Inc.
Packages
Package NDC Code Description
70204-513-01 30 ml in 1 bottle (70204-513-01)
70204-513-02 60 ml in 1 bottle (70204-513-02)
70204-513-03 118 ml in 1 bottle (70204-513-03)
70204-513-04 118 ml in 1 bottle, pump (70204-513-04)
70204-513-05 237 ml in 1 bottle, pump (70204-513-05)
70204-513-06 437 ml in 1 bottle, pump (70204-513-06)
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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 Wet hands thoroughly with product and allow to dry without wiping. For children under the age of 6 use only under adult supervision. Not recommended for infants.

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Inactive Ingredients Water, Peg-6 AMP-Acrylates/Vinyl Isodecanoate Crosspolymer, Propylene Glycol, Glycerin, Fragrance, Aloe Barbedenis 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.
Uses For Hand Sanitizing

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.
Antibacterial Hand Sanitizer Ethyl Alcohol PROPYLENE GLYCOL WATER GLYCERIN ALOE VERA LEAF 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.
Principal Display Panel Peel here for continued Drug Facts Antibacterial Hand Sanitizer 1 fl. oz. #94997 Hit® ASI-61125 Sanitizer Made in the USA Hit Promotional Products Inc. Bellmawr, NJ Lot: XXXXX Exp. Date: XXXXX 94997

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 call a Poison Control Center right away.

Other safety information

Information about safe use and handling of the product that may not have been specified in another field.
Other Information Do not store above 105°F. May discolor some fabric.

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 skin irritation develops.

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. In case of contact with eyes, flush thoroughly with water. Avoid contact with broken skin. Do not inhale or ingest.

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 – hands. Flammable. Keep away from heat and 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