Harmon Face Values Medicated
FDA Label NDC 63940-803

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Harmon Stores Inc. for the product Harmon Face Values Medicated (NDC 63940-803). 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 drug facts, 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

Drug Facts

Active Ingredient                                                                                      Purpose
Witch Hazel 50%................................................................................Astringent

Otc - Purpose

Uses

Temporarily relieves tehse externals ymptoms 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 occrus
  • 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
  • Gentle dry by patting or blotting with toilet tissue or soft cloth before applying
  • Gently apply to the afected 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 20° to 25°C (68° to 77°F)

Inactive Ingredient

Inactive Ingredients: alcohol, citric acid, diazolidinyl utea glycerin, methylparaben, propylene glycol, propylparaben, sodium citrate, water

Dosage & Administration

Distributed by: Harmon Stores, Inc.

650 Liberty Ave., Union, NJ 07083 USA

Made in China

Package Label.Principal Display Panel

Image Description (Harmonmedipads)

Image Description (Harmonmedipads)

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