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Advanced alcohol gel sanitizer - Medication Information

Product NDC Code 65601-801
Drug Name

Advanced alcohol gel sanitizer

Type Brand
Active Ingredients
Alcohol .7 ml/ml
Route TOPICAL
Dosage Form GEL
Application Number 505G(a)(3)
Labeler Name Betco Corporation, Ltd
Packages
Package NDC Code Description
65601-801-04 3780 ml in 1 bottle, plastic (65601-801-04)
65601-801-19 900 ml in 1 bag (65601-801-19)
65601-801-29 1000 ml in 1 bag (65601-801-29)
65601-801-55 208198 ml in 1 drum (65601-801-55)
65601-801-57 550 ml in 1 bottle, pump (65601-801-57)
65601-801-99 1041000 ml in 1 container (65601-801-99)
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active Ingredient Active Ingredient Ethyl Alcohol 70%

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 Directions • Read the entire label before using this product. • Place enough product on your palm to thoroughly cover your hands. • Rub hands together briskly until dry.

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Inactive Ingredients Inactive Ingredients Water, PEG/PPG-8/3 Laurate, Gycerin, Carbomer, Tetrahydroxypropylethylendiamine, Fragrance.

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 Uses • Hand sanitizer to reduce microorganisms on the skin. • Use this product when soap and water are not available.

Purpose

Information about the drug product’s indications for use.
Purpose Purpose Antiseptic

Spl product data elements

Usually a list of ingredients in a drug product.
Advanced Alcohol Gel Sanitizer Alcohol HEXYL SALICYLATE OCTOXYNOL-13 PROPYLENE OXIDE NEROL CITRONELLOL POLYETHYLENE GLYCOL, UNSPECIFIED .ALPHA.-PINENE LINALOOL ALLYL CYCLOHEXANEPROPIONATE LIMONENE, (+)- ACRYLIC ACID METHYL DIHYDROJASMONATE (SYNTHETIC) GERANIOL CYCLOHEXANE WATER CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) DIMETHICONE PEG-8 LAURATE GLYCERIN EDETOL .GAMMA.-TERPINENE ALCOHOL ALCOHOL ALOE BARBADENSIS LEAF EXTRACT

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 AdvancedAlcoholGelSanitizer

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.
Warnings KEEP OUT OF REACH OF CHILDREN.

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 Warnings • For external use only. • Avoid contact with eyes. If contact occurs, rinse thoroughly with water. • FLAMMABLE. This product contains ethyl alcohol. Keep away from sources of ignition. • Discontinue use if irritation or redness develops. • If irritation persists for more than 72 hours, consult a physician. • 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