Western Family Hygienic Cleansing
FDA Label NDC 55312-776

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Western Family Foods, Inc for the product Western Family Hygienic Cleansing (NDC 55312-776). 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 - keep out of reach of children, indications & usage, otc - ask doctor, 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 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 - Keep Out Of Reach Of Children

Stop use and ask a doctor if

  • Rectal bleeding occurs
  • Condition worsens or does not improve within 7 days

    • Keep out of reach of children. If swallowed, get medical help or contact a Poision 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

Otc - Ask Doctor

Children under 12 years of age: ask a doctor

Storage And Handling

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

Inactive Ingredient

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

Dosage & Administration

Distributed by:

Western Family Foods, Inc.

P.O. Box 4057

Portland, OR 97208 USA

www.westernfamily.com

Made in China

Package Label.Principal Display Panel

Image Description (13776)

Image Description (13776)

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