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Hand sanitizer - Medication Information

Product NDC Code 69396-137
Drug Name

Hand sanitizer

Type Brand
Active Ingredients
Alcohol 62 g/100g
Route TOPICAL
Dosage Form GEL
RxCUI drug identifier 581660
Application Number 505G(a)(3)
Labeler Name Trifecta Pharmaceuticals USA
Packages
Package NDC Code Description
69396-137-10 10 packet in 1 box (69396-137-10) / .9 g in 1 packet
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active Ingredient Alcohol 62% 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 Put enough product on your palm to cover hands and briskly rub hands together until dry.

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Inactive Ingredients Aloe barbadensis leaf juice, Acrylates/C10-30 alkyl acrylate crosspolymer, Fragrance, Glycerin, Maltodextrin, Propylene glycol, Tocopheryl acetate, Triethanoamine, 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 For hand sanitizing to decrease bacteria on skin without soap and water

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.
Hand Sanitizer Alcohol .ALPHA.-TOCOPHEROL ACETATE ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER (60000 MPA.S) TROLAMINE FRAGRANCE 13576 ALCOHOL ALCOHOL PROPYLENE GLYCOL MALTODEXTRIN GLYCERIN ALOE VERA LEAF WATER

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 R519521 Globe Hand Sanitizer 0.9g 10pk 100423 CDER

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.
Other Information Do not store above 105°F May discolor some fabrics Harmful to wood finishes and plastic Other Information Distributed By: Trifecta Pharmaceuticals USA® 101 NE Third Avenue, Suite 1500 Ft. Lauderdale, FL. 33301 USA www.trifecta-pharma.com 1-888-296-9067

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 in the eyes

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 For Children under 6 years old, use only under adult supervision

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 Use with caution if allergic to alcohol. Flammable. Keep away from heat or flames.

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