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| Product NDC Code | 55910-331 | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Drug Name | Rexall hemorrhoidal |
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| 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] |
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| Active Ingredients |
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| Route | TOPICAL | ||||||||
| Dosage Form | CREAM | ||||||||
| Application Number | part346 | ||||||||
| Labeler Name | Dolegencorp,LLC | ||||||||
| 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.Active ingredients Purposes Glycerin 14.4% Protectant Petrolatum 15% Protectant Phenylephrine hydrochloride 0.25% Vasoconstrictor Pramoxine hydrochloride 1% Local anesthetic
| Glycerin 14.4% | Protectant |
| Petrolatum 15% | Protectant |
| Phenylephrine hydrochloride 0.25% | Vasoconstrictor |
| Pramoxine hydrochloride 1% | Local anesthetic |
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 affected area by patting or blotting with appropriate cleansing wipe. Gently dry by patting or blotting with tissue or soft cloth before applying cream. when first opening tube, remove foil seal apply externally or in lower portion of anal canal only apply externally to affected area up to 4 times daily, especially at night, in the morning, or after each bowel movement for application in lower anal canal; remove cover from dispensing cap. Attach dispensing cap to tube. Lubricate dispensing cap well, then gently insert dispensing cap partway into anus thoroughly cleanse dispensing cap after each use, and replace cover Children under 12 years: ask a doctor
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients aloe barbadensis leaf juice, BHA, cetyl alcohol, citric acid, disodium EDTA, glyceryl stearate, laureth-23, mineral oil, panthenol, pheoxy ethenol, propyl gallate, propylene glycol, purified water, sodium benzoate, sodium carboxymethylcellulose, steareth-2, steareth-20, stearyl alcohol, tocopherol (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 temporarily relieves pain, soreness, and burning helps relieve local itching and discomfort associated with hemorrhoids temporarily shrinks hemorrhoidal tissue 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 Petrolatum 15% Protectant Phenylephrine hydrochloride 0.25% Vasoconstrictor Pramoxine hydrochloride 1% Local anesthetic
| Glycerin 14.4% | Protectant |
| Petrolatum 15% | Protectant |
| Phenylephrine hydrochloride 0.25% | Vasoconstrictor |
| Pramoxine hydrochloride 1% | Local anesthetic |
Spl product data elements
Usually a list of ingredients in a drug product.Rexall Hemorrhoidal Glycerin, Phenylephrine Hydrochloride, Pramoxine Hydrochloride, and Petrolatum Glycerin Glycerin Phenylephrine Hydrochloride Phenylephrine Pramoxine Hydrochloride Pramoxine Petrolatum Petrolatum Aloe Vera Leaf Butylated Hydroxyanisole CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED Cetostearyl Alcohol Citric Acid Monohydrate Edetate Disodium Glyceryl Monostearate Laureth-23 Mineral Oil Panthenol Propyl Gallate Propylene Glycol Sodium Benzoate Steareth-2 Steareth-20 Stearyl Alcohol Tocopherol .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 - 28 g Tube Carton NDC 55910-331-24 Since 1903 Rexall ® MAXIMUM STRENGTH Hemorrhoidal Cream Rapid, soothing pain relief from burning, itching and discomfort Protects irritated tissue NET WT 1 OZ (28 g) PRINCIPAL DISPLAY PANEL - 28 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: 800-222-1222.
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 feedingIf 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) Tamper Evident: DO NOT USE IF SEAL ON TUBE IS PUNCTURED OR MISSING.
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: 800-222-1222.
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