Health Mart Medicated Cooling
FDA Label NDC 62011-0331

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Mckesson (health Mart) for the product Health Mart Medicated Cooling (NDC 62011-0331). 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 - when using, otc - stop use, otc - keep out of reach of children, indications & usage, storage and handling, 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

Witch hazel 50%..........................................Astringent

Otc - Purpose

Uses

  • temporarily relieves the local itching and discomfort associated with hemorrhoids
  • aids in protecting irritated anorectal areas
  • temporarily relieves irritation and burning

Warnings

Warnings

For external use only

Otc - When Using

When using this product

  • do not use more than directed unless told to do so by a doctor
  • do not put directly in rectum by using fingers or any mechanical deviec or applicator

Otc - Stop Use

Stop use and ask a doctor if

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

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:

  • when practical, 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 6 times daily or after each bowl movement
  • after application, discard pad

    • Children under 12 years of age: ask a doctor

Storage And Handling

Other information store at 68° to 77°F (20° to 25°C)

Inactive Ingredient

Inactive ingredients

alcohol, citric acid, diazolidinyl urea, glycerin, methylparaben, propylene glycol, propylparaben, sodium citrate, water

Package Label.Principal Display Panel

Image Description (14079.1)

Image Description (14079.1)

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