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Alcohol - Medication Information

Product NDC Code 11344-849
Drug Name

Alcohol

Type Generic
Active Ingredients
Alcohol 62 ml/100ml
Route TOPICAL
Dosage Form LIQUID
RxCUI drug identifier 247835
Application Number 505G(a)(3)
Labeler Name Consumer Product Partners, LLC
Packages
Package NDC Code Description
11344-849-16 59 ml in 1 bottle, plastic (11344-849-16)
11344-849-34 236 ml in 1 bottle, plastic (11344-849-34)
11344-849-45 946 ml in 1 bottle, plastic (11344-849-45)
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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 wet hands thoroughly with product and allow to dry without wiping for children under 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, carbomer or acrylates/C10-30 alkyl acrylate crosspolymer, fragrance, glycerin, isopropyl myristate, tocopheryl acetate

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 to decrease bacteria on the skin that could cause disease 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.
Alcohol Alcohol WATER CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) GLYCERIN ISOPROPYL MYRISTATE TOCOPHEROL 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 panel display SIMPLY U Moisturizing Hand Sanitizer With Vitamin E Kills 99.99% of germs* Formula made in USA Employee-Owned 32 FL OZ (946 mL) 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.
Claims MOISTURIZING HAND SANITIZER WITH VITAMIN E Claims *Effective at eliminating 99.99% of many common harmful germs & bacteria in as little as 15 seconds. Distributed By: Vi-Jon, LLC St. Louis, MO 63114

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 and redness develop condition persists for more than 72 hours

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 thoroghly with water. avoid contact with broken skin do not inhale or ingest

Storage and handling

Information about safe storage and handling of the drug product.
Other information do not store above 105⁰F may discolor some fabrics harmful to wood finishes and plastics

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 exterenal use only: hands Flammable, keep away from fire 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