Cvs Hemorrhoidal Topical Analgesic
FDA Label NDC 59779-997

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 Cvs Hemorrhoidal Topical Analgesic (NDC 59779-997). 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, warnings, otc - do not use, otc - when using, otc - stop use, otc - pregnancy or breast feeding, otc - 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

Otc - Active Ingredient

Active Ingredient                                 Purpose

Dibucaine 1%...................................... Local anesthetic

Otc - Purpose

Use

temporarily relives pain and itching due to hemorrhoids or other anorectal disorders

Warnings

Warnings

For external use only

Allergy Alert

  • Certain persons can develop allergic reactions to ingredietns in this product. If the symptoms being treated does not subside or if redness, irritation, swelling, bleeding or other symptoms develop or increase, discontinue use and ask a doctor.

Otc - Do Not Use

Do not use

  • in or near the eyes
  • in children under 2 years of age

Otc - When Using

When using this product

  • do not use more than directed unless directed by a doctor
  • do not put this product into the rectum by using fingers or any mechanical device or applicator

Otc - Stop Use

Stop use and ask a doctor if

  • bleeding occurs
  • condition worsens or does not improve within 7 days

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding, ask a health professional before use.

Otc - 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.

Indications & Usage

Directions

  • adults and children 12 years and over: if possible, clean the affected area with mild soap and warm water and rinse thoroughly. Gently dry by patting or blotting with toilet tissue or a soft cloth before applying
  • apply externally to the affected area up to 3 or 4 times daily
  • children under 12 years of age: ask a doctor

Storage And Handling

Other information

store at 20-25°C (68-77°F)

Inactive Ingredient

Inactive ingredients

disodium EDTA, distilled water, lanolin, mineral oil, white petrolatum

Dosage & Administration

DISTRIBUTED BY:

CVS PHARMACY, INC.

ONE CVS DRIVE

WOONSOCKET, RI 02895 USA

Package Label.Principal Display Panel

Image Description (42136)

Image Description (42136)

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