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| Product NDC Code | 0573-2871 | ||||||||||||||||
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| Drug Name | Preparation h |
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| Type | Brand | ||||||||||||||||
| Pharm Class | Adrenergic alpha1-Agonists [MoA], alpha-1 Adrenergic Agonist [EPC] |
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| Active Ingredients |
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| Route | TOPICAL | ||||||||||||||||
| Dosage Form | OINTMENT | ||||||||||||||||
| RxCUI drug identifier | 1372298 | ||||||||||||||||
| Application Number | M015 | ||||||||||||||||
| Labeler Name | Haleon US Holdings LLC | ||||||||||||||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.ACTIVE INGREDIENTS Mineral oil 14% Petrolatum 74.9% Phenylephrine HCl 0.25%
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 a soft cloth before applying ointment. when first opening the tube, puncture foil seal with top end of cap apply to the affected area up to 4 times daily, especially at night, in the morning or after each bowel movement intrarectal use: remove cover from applicator, attach applicator to tube, lubricate applicator well and gently insert applicator into the rectum thoroughly cleanse applicator after each use and replace cover also apply ointment to external area regular use provides continual therapy for relief of symptoms children under 12 years of age: ask a doctor
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.INACTIVE INGREDIENTS benzoic acid, butylated hydroxyanisole, corn oil, glycerin, lanolin, lanolin alcohols, methylparaben, mineral oil, paraffin, propylparaben, purified water, thymus vulgaris (thyme) flower/leaf oil, tocopherols excipient, white wax
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 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.PURPOSES Protectant Protectant Vasoconstrictor
Spl product data elements
Usually a list of ingredients in a drug product.PREPARATION H mineral oil, petrolatum, phenylephrine HCl BENZOIC ACID BUTYLATED HYDROXYANISOLE CORN OIL GLYCERIN LANOLIN LANOLIN ALCOHOLS METHYLPARABEN PARAFFIN PROPYLPARABEN WATER THYME WHITE WAX TOCOPHEROL PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE MINERAL OIL MINERAL OIL PETROLATUM PETROLATUM smooth yellow ointment
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 - 28 g Tube Label THIS PACKAGE CONTAINS AN OUTER CARTON. DO NOT BUY IF OUTER CARTON IS MISSING. PREPARATION H ® HEMORRHOIDAL OINTMENT Prevents Further Irritation Prompt, Soothing Relief from Painful Burning, Itching and Discomfort Shrinks Swollen Hemorrhoidal Tissue Protects Irritated Tissue Relieves Internal and External Discomfort NET WT 1 OZ (28 g) Principal Display Panel - 28 g Tube Label
PRINCIPAL DISPLAY PANEL - 28 g Tube Carton PREPARATION H ® HEMORRHOIDAL OINTMENT Prevents Further Irritation Prompt, Soothing Relief from Painful Burning, Itching and Discomfort Shrinks Swollen Hemorrhoidal Tissue Protects Irritated Tissue Relieves Internal and External Discomfort NET WT 1 OZ (28 g) Principal Display Panel - 28 g Tube Carton
PRINCIPAL DISPLAY PANEL - 28 g Tube Label - PAA119867 PREPARATION H ® HEMORRHOIDAL OINTMENT Prevents Further Irritation Prompt, Soothing Relief from Painful Burning, Itching, & Discomfort Shrinks Swollen Hemorrhoidal Tissue Protects Irritated Tissue Relieves Internal & External Discomfort NET WT 1.0 OZ (28 g) PRINCIPAL DISPLAY PANEL - 28 g Tube Label - PAA119867
PRINCIPAL DISPLAY PANEL - 28 g Tube Carton - PAA119868 PREPARATION H ® HEMORRHOIDAL OINTMENT Prevents Further Irritation New Look, SAME SIZE! Prompt, Soothing Relief from Painful Burning, Itching, & Discomfort Shrinks Swollen Hemorrhoidal Tissue Protects Irritated Tissue Relieves Internal & External Discomfort 1 TUBE | NET WT 1 OZ (28 g) PRINCIPAL DISPLAY PANEL - 28 g Tube Carton - PAA119868
PRINCIPAL DISPLAY PANEL - 57 g Tube Label PREPARATION H ® HEMORRHOIDAL OINTMENT Prevents Further Irritation Prompt, Soothing Relief from Painful Burning, Itching, & Discomfort Shrinks Swollen Hemorrhoidal Tissue Protects Irritated Tissue Relieves Internal & External Discomfort NET WT 2.0 OZ (57 g) PRINCIPAL DISPLAY PANEL - 57 g Tube Label
PRINCIPAL DISPLAY PANEL - 57 g Tube Carton PREPARATION H ® HEMORRHOIDAL OINTMENT Prevents Further Irritation Prompt, Soothing Relief from Painful Burning, Itching, & Discomfort Shrinks Swollen Hemorrhoidal Tissue Protects Irritated Tissue Relieves Internal & External Discomfort 1 TUBE | NET WT 2 OZ (57 g) PRINCIPAL DISPLAY PANEL - 57 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.OTHER INFORMATION store at 20-25°C (68-77°F)
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 in urination 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 presently 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? Call weekdays 9 AM to 5 PM EST at 1-800-99PrepH or 1-800-997-7374.
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 condition worsens or does not improve within 7 days introduction of applicator into the rectum causes additional pain
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.
Pregnancy or breast feeding
Pregnancy or Breast feedingIf pregnant or breast-feeding, ask a health professional before use.
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 and/or intrarectal use only Ask a doctor before use if you have heart disease high blood pressure thyroid disease diabetes difficulty in urination due to enlargement of the prostate gland Ask a doctor or pharmacist before use if you are presently 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. Stop use and ask a doctor if bleeding occurs condition worsens or does not improve within 7 days introduction of applicator into the rectum causes additional pain 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