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Pramoxine hydrochloride - Medication Information

Product NDC Code 51862-180
Drug Name

Pramoxine hydrochloride

Type Generic
Active Ingredients
Pramoxine hydrochloride 10 mg/g
Route TOPICAL
Dosage Form AEROSOL, FOAM
RxCUI drug identifier 828365
Application Number part346
Labeler Name Mayne Pharma
Packages
Package NDC Code Description
51862-180-15 1 container in 1 carton (51862-180-15) / 15 g in 1 container
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
ACTIVE INGREDIENT: Pramoxine hydrochloride 1%.

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: SHAKE WELL BEFORE USE. Dispense Pramoxine Hydrochloride 1% onto a clean tissue or pad and apply externally to the affected area up to 5 times daily. See carton for additional directions for use.

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
INACTIVE INGREDIENTS: Cetyl alcohol, emulsifying wax, methylparaben, polyoxyethylene C12-C14 ether, PPG5 Ceteth-20, propylene glycol, propylparaben, purified water, sorbitan trioleate, trolamine, and inert propellant: tetrafluoroethane.

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.
INDICATION: Use for the temporary relief of pain and itching associated with hemorrhoids.

Spl product data elements

Usually a list of ingredients in a drug product.
Pramoxine hydrochloride Pramoxine hydrochloride PRAMOXINE HYDROCHLORIDE PRAMOXINE CETYL ALCOHOL YELLOW WAX METHYLPARABEN CETETH-20 PROPYLENE GLYCOL PROPYLPARABEN WATER SORBITAN TRIOLEATE TROLAMINE TETRAFLUOROMETHANE

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 - 15 g Container Carton NDC 51862-180-15 Pramoxine Hydrochloride 1% For external use only Hemorrhoidal Foam-Non Steroid SHAKE WELL BEFORE USING Net Wt. 0.53 oz. (15 g) Foam mayne pharma PRINCIPAL DISPLAY PANEL - 15 g Container Carton

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.
Distributed by: Mayne Pharma Greenville, NC 27834 Net Wt. 0.53 oz (15 g) HOLD UPRIGHT TO DISPENSE

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 this and all drugs out of the reach of children. In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.

Safe handling warning

Safe Handling Warning
CAUTION: FOR EXTERNAL USE ONLY. Do not insert any part of the aerosol container into the rectum. Contents of the container are under pressure. Do not burn or puncture the aerosol container. Do not store at temperatures above 49°C (120°F). STORE UPRIGHT AT CONTROLLED ROOM TEMPERATURE 20°-25°C (68°-77°F). DO NOT REFRIGERATE.

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: Do not exceed the recommended daily dosage unless directed by a physician. If condition worsens or does not improve within 7 days, consult a physician. In case of rectal bleeding, consult a physician promptly. Do not put this product into the rectum by using fingers or any mechanical device or applicator. Certain persons can develop allergic reactions to ingredients in this product. If the symptom being treated does not subside or if redness, irritation, swelling, pain or other symptoms develop or increase, discontinue use immediately and consult a physician. Do not use in the eyes or nose. Do not apply to large areas of the body.

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