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Prestige - Medication Information

Product NDC Code 63621-335
Drug Name

Prestige

Type Brand
Active Ingredients
Chloroxylenol 10 mg/ml
Route TOPICAL
Dosage Form SOAP
RxCUI drug identifier 413257
Application Number 505G(a)(3)
Labeler Name Sunburst Chemicals, Inc.
Packages
Package NDC Code Description
63621-335-14 3785 ml in 1 bottle, plastic (63621-335-14)
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active Ingredient Chloroxylenol 1% w/w

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 and forearms. Apply a small amount (5 mL) or palmful to hands and forearms. Scrub thoroughly for at least fifteen seconds. Rinse completely and dry.

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Inactive Ingredients Water, Sodium C14-16 Olefin Sulfonate, Sodium Laureth Sulfate, Lauramide DEA, Isopropyl Alcohol, Polyquaternium-7, Fragrance, Styrene/Acrylates Copolymer, Tetrasodium EDTA, Citric Acid

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.
Use reduces amount of bacteria on hands

Purpose

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

Spl product data elements

Usually a list of ingredients in a drug product.
Prestige Chloroxylenol WATER LAURAMINE OXIDE EDETATE SODIUM ISOPROPYL ALCOHOL POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600000 MW) CITRIC ACID MONOHYDRATE SODIUM C14-16 OLEFIN SULFONATE SODIUM LAURETH SULFATE CHLOROXYLENOL CHLOROXYLENOL white, opaque liquid

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.
Product Label - 1 Gallon ShortNeck Bottle

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.
Not for use on children under 6 months of age. For institutional and professional use only.

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. Do not use in eyes. Discontinue use if irritation and redness develop. If condition persists for more than 72 hours, consult a physician. Not for use on children under 6 months of age. For institutional and professional use only.

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