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Hemorrhoidal anesthetic - Medication Information

Product NDC Code 71003-001
Drug Name

Hemorrhoidal anesthetic

Type Brand
Pharm Class Adrenergic alpha1-Agonists [MoA],
Allergens [CS],
Cell-mediated Immunity [PE],
Glycerol [CS],
Increased Histamine Release [PE],
Increased IgG Production [PE],
Non-Standardized Chemical Allergen [EPC],
alpha-1 Adrenergic Agonist [EPC]
Active Ingredients
Glycerin 144 mg/g
Petrolatum 150 mg/g
Phenylephrine hydrochloride 2.5 mg/g
Pramoxine hydrochloride 10 mg/g
Route TOPICAL
Dosage Form CREAM
RxCUI drug identifier 1293649
Application Number part346
Labeler Name Purity Products
Packages
Package NDC Code Description
71003-001-01 1 tube in 1 carton (71003-001-01) / 25 g in 1 tube
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active Ingredients Purposes Glycerin 14.4% Protectant Phenylephrine HCl 0.25% Vasoconstrictor Pramoxine HCl 1% Local Anesthetic White petrolatum 15% Protectant
Active Ingredients Purposes
Glycerin 14.4% Protectant
Phenylephrine HCl 0.25% Vasoconstrictor
Pramoxine HCl 1% Local Anesthetic
White petrolatum 15% Protectant

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 Adults: when practical, cleanse the affected area by patting or blotting with an appropriate cleansing wipe. Gently dry by patting or blotting with a tissue or soft cloth before applying the cream When first opening the tube, remove the foil seal Apply externally or in the lower portion of the anal canal only Apply externally to the affected area up to 4 times daily, especially at night, in the morning, or after each bowel movement For application in the lower anal canal; remove the cover from the dispensing cap. Attach the dispensing cap to the tube. Lubricate the dispensing cap well, then gently insert the dispensing cap partway into the anus. Thoroughly cleanse the dispensing cap after each use, and replace the cover Children under 12 years: ask a doctor

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Inactive Ingredient Aloe barbadensis leaf extract, anhydrous citric acid, butylated hydroxyanisole, cetyl alcohol, edetate disodium, glyceryl monostearate, laureth-23, methylparaben, mineral oil, panthenol, propyl gallate, propylene glycol, propylparaben, purified water, sodium benzoate, sodium carboxymethyl cellulose, steareth-2, steareth-20, stearyl alcohol, vitamin E acetate, xanthan gum

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 temporary relief of pain, soreness and burning Helps relieve the local itching and discomfort associated with hemorrhoids Temporarily shrinks hemorrhoidal tissue and relieves burning Temporarily provides a coating for relief of anorectal discomforts Temporarily protects the inflamed, irritated anorectal surface to help make bowel movements less painful

Purpose

Information about the drug product’s indications for use.
Active Ingredients Purposes Glycerin 14.4% Protectant Phenylephrine HCl 0.25% Vasoconstrictor Pramoxine HCl 1% Local Anesthetic White petrolatum 15% Protectant
Active Ingredients Purposes
Glycerin 14.4% Protectant
Phenylephrine HCl 0.25% Vasoconstrictor
Pramoxine HCl 1% Local Anesthetic
White petrolatum 15% Protectant

Spl product data elements

Usually a list of ingredients in a drug product.
Hemorrhoidal Anesthetic Glycerin, Phenylephrine Hydrochloride, Pramoxine Hydrochloride, and Petrolatum GLYCERIN GLYCERIN PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE PRAMOXINE HYDROCHLORIDE PRAMOXINE PETROLATUM PETROLATUM ALOE VERA LEAF BUTYLATED HYDROXYANISOLE CETYL ALCOHOL CITRIC ACID MONOHYDRATE EDETATE DISODIUM ANHYDROUS GLYCERYL MONOSTEARATE LAURETH-23 METHYLPARABEN MINERAL OIL PANTHENOL PROPYL GALLATE PROPYLENE GLYCOL PROPYLPARABEN SODIUM BENZOATE CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM STEARETH-2 STEARETH-20 STEARYL ALCOHOL .ALPHA.-TOCOPHEROL WATER XANTHAN GUM

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 - 25.5 G Tube Carton NET WT. 0.9 OZ (25.5 G) Save Uranus RAPID SOOTHING Relief & Comfort MAXIMUM STRENGTH FOR PAINFUL BURNING, ITCHING, & DISCOMFORT. PRINCIPAL DISPLAY PANEL - 25.5 G Tube 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.
Drug Facts

Ask doctor

Information about when a doctor should be consulted about existing conditions or sumptoms before using the drug product, including all warnings for persons with certain preexisting conditions (excluding pregnancy) and all warnings for persons experiencing certain symptoms. The warnings under this heading are those intended only for situations in which consumers should not use the product until a doctor is consulted.
Ask a doctor before use if you have Heart disease High blood pressure Thyroid disease Diabetes Difficulty urinating due to enlargement of the prostate gland

Ask doctor or pharmacist

Information about when a doctor or pharmacist should be consulted about drug/drug or drug/food interactions before using a drug product.
Ask a doctor or pharmacist before use if you are taking a prescription drug for high blood pressure or depression

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.

Questions

A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.
Questions or comments? To Reorder Call: 1-800-281-7781, Customer Care: 1-888-769-7873 or www.purityproducts.com

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 Bleeding occurs the condition worsens or does not improve within 7 days An allergic reaction develops The symptom being treated does not subside or if redness, irritation, swelling, pain or other symptoms develop or increase

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 Do not exceed the recommended daily dosage unless directed by a doctor Do not put into the rectum by using fingers or any mechanical device or applicator

Pregnancy or breast feeding

Pregnancy or Breast feeding
If pregnant or breast-feeding , ask a health professional before use.

Storage and handling

Information about safe storage and handling of the drug product.
Other Information Store at 15 to 30°C (59 to 86°F)

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 Ask a doctor before use if you have Heart disease High blood pressure Thyroid disease Diabetes Difficulty urinating due to enlargement of the prostate gland Ask a doctor or pharmacist before use if you are taking a prescription drug for high blood pressure or depression When using this product Do not exceed the recommended daily dosage unless directed by a doctor Do not put into the rectum by using fingers or any mechanical device or applicator Stop use and ask a doctor if Bleeding occurs the condition worsens or does not improve within 7 days An allergic reaction develops The symptom being treated does not subside or if redness, irritation, swelling, pain or other symptoms develop or increase If pregnant or breast-feeding , ask a health professional before use. 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