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| Product NDC Code | 13709-319 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | Hemorrhoidal |
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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 | RECTAL | ||||||
| Dosage Form | OINTMENT | ||||||
| RxCUI drug identifier | 1372298 | ||||||
| Application Number | M015 | ||||||
| Labeler Name | NeilMed Pharmaceuticals Inc. | ||||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.Drug Facts Active Ingredients Mineral oil 14% Petrolatum 74.9% Phenylephrine Hydrochloride 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 hydroxytoluene, corn oil, glycerin, lanolin, lanolin alcohol, methylparaben, propylparaben, paraffin wax, purified water, thymus vulgaris oil, tocopherol acetate, 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.Active Ingredients Purpose Mineral oil 14% ..................................................................... Protectant Petrolatum 74.9%................................................................. Protectant Phenylephrine Hydrochloride 0.25% ...............................Vasoconstrictor
Spl product data elements
Usually a list of ingredients in a drug product.Hemorrhoidal Pain Relief PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE PARAFFIN LANOLIN BENZOIC ACID BUTYLATED HYDROXYANISOLE GLYCERIN LANOLIN ALCOHOLS PETROLATUM PETROLATUM MINERAL OIL MINERAL OIL CORN OIL WHITE WAX TOCOPHEROL PROPYLPARABEN WATER THYME
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.Hemorrhoidal Ointment
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: Ask a doctor before use if you have: Heart disease High blood pressure Thyroid disease Diabetes Difficulty in urination due to enlargement of 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 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 Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away (1-800-222-1222).
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Important: Please do not discard this printed box and any enclosed printed material. The inside final product may not have all the details you require for the ongoing use of the product.
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 doctor if: Stop use and ask 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, If pregnant or breast-feeding, ask a health professional before use.
Safe handling warning
Safe Handling WarningTAMPER EVIDENT DO NOT USE IF SEAL ON TUBE IS PUNCTURED OR MISSING TAMPER EVIDENT DO NOT USE IF SEAL ON TUBE IS PUNCTURED OR MISSING
Storage and handling
Information about safe storage and handling of the drug product.Other information: Store at 15°C - 30°C (59°F - 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: Warnings: For external and/or intrarectal 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