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Spectrum - Medication Information

Product NDC Code 53329-009
Drug Name

Spectrum

Type Brand
Active Ingredients
Alcohol 70 g/100ml
Route TOPICAL
Dosage Form GEL
RxCUI drug identifier 581662
Application Number 505G(a)(3)
Labeler Name Medline Industries, LP
Packages
Package NDC Code Description
53329-009-02 2.4 ml in 1 packet (53329-009-02)
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active ingredient Ethyl alcohol 70% v/v

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 Acrylates/C10-30 alkyl acrylate crosspolymer, aloe barbadensis leaf juice, diisopropylamine, glycerin, isopropyl myristate, tocopheryl acetate, water

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 repeat 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.
Spectrum Ethyl alcohol DIISOPROPYLAMINE ALPHA-TOCOPHEROL ACETATE GLYCERIN WATER ALOE VERA LEAF ISOPROPYL MYRISTATE CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) 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 label

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.
Manufacturing Information Manufactored for Medline industries, LP Three Lakes Drive, Northfield, IL 60093 USA Made in USA with US and Foreign components www.medline.com 1-800-MEDLINE REF: HH70GPACKET V1 RA22VJO

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 redness develops 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 thoroughly 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 105ºF 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 external use only. Flammable: keep away from heat and flame. 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 Stop use and ask a doctor if irritation or redness develops condition persists for more than 72 hours Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

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