Cvs Hemorrhoidal
FDA Label NDC 59779-403

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Cvs Pharmacy for the product Cvs Hemorrhoidal (NDC 59779-403). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, otc - keep out of reach of children, indications & usage, warnings, dosage & administration, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Otc - Active Ingredient

Active ingredients                                 PurposeGlycerin 14.4%.................................................ProtectantPetrolatum 15.0%.............................................ProtectantPhenylephrine Hydrochloride.............................VasoconstrictorPramoxine Hydrochloride..................................Local anesthetic

Otc - Purpose

Active ingredients                                 PurposeGlycerin 14.4%.................................................Protectant Petrolatum 15.0%.............................................Protectant Phenylephrine Hydrochloride.............................Vasoconstrictor Pramoxine Hydrochloride..................................Local anestheticUses- for temporary relief of pain, soreness and burning - helps relieve the 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

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If swallowed, get medical help or contacta Poison Control Center right away.

Indications & Usage

Uses- for temporary relief of pain, soreness and burning - helps relieve the 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 Other information- store at 20 degrees - 25 degrees C (68 degrees - 77 degrees F)

Warnings

Warnings For external use only. Ask a doctor before use if you have- heart disease - high blood pressure - thyroid disease - diabetes - trouble urinating due to an enlarged prostate glandAsk a doctor or pharmacist before use if you are presently taking a prescription drug for high blood pressure or depressionWhen using this product - do not exceed the recommended daily dosage unless directed by a doctor- do not put into rectum by using fingers or any mechanical device or applicatorStop use and ask a doctor if- bleeding occurs- 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 increaseIf pregnant or breast feeding, ask a health professional before use.Keep out of the reach of children. If swallowed, get medical help or contact a Poison Control Center right away

Dosage & Administration

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 cream.- When first opening the tube, puncture foil seal with top end of cap.- 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 cover from dispensing cap. Attach dispensing cap to tube. Lubricate dispensing cap well, then gently insert cap partway into the anus.- thoroughly cleanse dispensing cap after each use and replace cover- children under 12 years of age: ask a doctor

Inactive Ingredient

Inactive Ingredients aloe barbadensis leaf juice, butylated hydroxyanisole, cellulose gum, cetyl alcohol, citric acid, disodium EDTA, glyceryl stearate SE, laureth-23, methylparaben, mineral oil, penthenol, propylene glycol, propyl gallate, propylparaben, purified water, sodium benzoate, steareth-2, steareth-20, stearyl alcohol, tocopheryl acetate, xanthan gum

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