Maximum Strength Hemorrhoidal Relief Cream
FDA Label NDC 51316-226

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, Inc for the product Maximum Strength Hemorrhoidal Relief (NDC 51316-226). 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 active ingredients, purpose, use, warnings, when using this product, stop use and ask a doctor if, if pregnant or breastfeeding, keep out of reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients

Glycerin 14.4%

Lidocaine 5%

Phenylephrine HCl 0.25%

White petrolatum 15%

Purpose

Local anesthetic

Use

helps relieve the pain, itching and burning associated with hemorrhoids and other anorectal disorders.

Warnings

For external use only.

When Using This Product

  • avoid contact with the eyes
  • 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

  • rectal bleeding occurs
  • condition worsens or does not improve within 7 days
  • allergic reaction occurs to ingredients in this product
  • symptom being treated does not subside or if redness, irritation, swelling, pain or other symptoms develop or increase
  • symptoms clear up and return within a few days

If Pregnant Or Breastfeeding

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.

Directions

  • when practical, clean area with mild soap and warm water and rinse thoroughly. Gently dry by patting or blotting with toilet tissue or soft cloth before applying.
  • adults and children 12 years and older: apply externally to the affected area up to 6 times a day.
  • children under 12 years of age: consult a doctor
  • To use finger cots: Roll one finger cot over finger. Gently squeeze cream onto finger cot. Smooth a layer of the cream over affected area.

Other Information

store at room temperature 68° - 77° F (20° - 25° C)

Inactive Ingredients

aloe oil, benzyl alcohol, carbomer 940, cholesterol, isopropyl myristate, mineral oil, polysorbate 80, propylene glycol,  purified water, trolamine, vitamin E

Questions?

1-800-639-3803 Weekdays 9 AM to 4 PM EST

* Please review the disclaimer below.