FDA Label for Gnp Medicated Wipes

View Indications, Usage & Precautions

Gnp Medicated Wipes Product Label

The following document was submitted to the FDA by the labeler of this product Amerisource Bergen. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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




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