Family Wellness Medicated Cooling Pads
FDA Label NDC 55319-032

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Family Dollar for the product Family Wellness Medicated Cooling Pads (NDC 55319-032). 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 these external symptoms associated with hemorrhoids: itching, burning, and irritation

Warnings

Warnings

For external use only.  Avoid contact with eyes.

Otc - When Using

When using this product

  • Do not exceed the recommended daily dosage unless directed by a doctor
  • Do not put directly in rectum by using fingers or any mechanical device

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

  • As hemorrhoidal treatment for 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 soft cloth before applying
  • Gently apply to the affected area by patting and then discard
  • Can be used up to six times daily or after each bowel movement
  • Children under 12 years of age: ask a doctor

Storage And Handling

Other information

Store at 20o to 25oC (68o to 77oF)

Inactive Ingredient

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

Dosage & Administration

DISTRIBUTED BY: FAMILY DOLLAR SERVICES, INC.

10401 MONROE RD, MATTHEWS, NC 28105 USA

MADE IN CHINA

Package Label.Principal Display Panel

Image Of Carton Label (Fwmedicatedpads)

Image Of Carton Label (Fwmedicatedpads)

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