Gnp Medicated Wipes
FDA Label NDC 46122-055

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Amerisource Bergen for the product Gnp Medicated Wipes (NDC 46122-055). 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 - ask doctor, otc - do not use, otc - pregnancy or breast feeding, otc - keep out of reach of children, indications & usage, 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% v/v...................................................Astringent

Otc - Purpose

Uses For temporary relief of local discomfort itching, burning, and irritation associated with hemorrhoids

Warnings

Warnings For external use only. Avoid contact with eyes.

Otc - Ask Doctor

Consult a doctor

  • if condition worsens or does not improve within 7 days
  • in case of bleeding
  • before exceeding the recommended dosage

Otc - Do Not Use

Do not put this product into rectum using fingers or any mechanical device or applicator.

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 older: up to 6 times daily or after each bowel movement
  • Children under 12: consult a doctor
  • When practical, cleanse 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 each application of this product. Gently apply to the affected area by patting and discard. Apply to the affected area up to 6 times daily or after each bowel movement.

Storage And Handling

Other information Store at room temperature: 15° - 30 °C (59° - 86°F)

Inactive Ingredient

Inactive ingredient aloe barbadensis gel, citric acid, diazolidinyl urea, glycerin, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate

Dosage & Administration

Distributed By

Amerisource Bergen

1300 Morris Drive

Chesterbrook, PA 19067


Package Label.Principal Display Panel

Image Of Carton Label (Pa 408812 Pl Ame Medicated Wipes 48ct)

Image Of Carton Label (Pa 408812 Pl Ame Medicated Wipes 48ct)

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