FDA Label for Medicated Hemorrhoidal Pads

View Indications, Usage & Precautions

Medicated Hemorrhoidal Pads Product Label

The following document was submitted to the FDA by the labeler of this product Cardinal Health. 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.

Active Ingredient



Witch hazel 50%



Purpose



Astringent


Uses



  • provides temporary relief of local itching and discomfort associated with hemorrhoids
  • temporary relief of irritation and burning.
  • aids in protecting irritated anorectal areas.

Warnings



For external use only.


When Using This Product



  • do not use more than directed unless told to do so by a doctor
  • do not put directly in the rectum by using fingers or any mechanical device or applicator.

Stop Use And Ask A Doctor If



  • bleeding occurs
  • condition worsens or does not improve within 7 days

Keep Out Of Reach Of Children.



If swallowed, get medical help or contact Poison Control Center right away. (1-800-222-1222).



Directions



  • adults: cleane the affected area with mild soap and warm water, and rinse thoroughly
  • gently dry by patting or blotting with toilet tissue prior to applying.
  • apply externally to the affected area up to 6 times daily or after each bowel movement
  • dispose of pad in thrash after use and wash hands, do not flush
  • children under 12 years of age: consult a doctor

Other Information



  • store at room temperature 15- 30oC (59 - 86oF)
  • for use as a moist compress - if necessary, first cleanse the area and place wipe in contact with irritated area for a soothing and cooling effect. Leave in place for up to 15 minutes and repeat as needed but not to exceed directions for use.

Inactive Ingredients



Water, Alcohol, Glycerin, Phenoxyethanol, Aloe, Decyl Glucoside, Potassium Sorbate, Propylene Glycol, Sodium Benzoate, Citric Acid.



Questions Or Comments?



(800) 320-6603


Principal Display Panel



LEADERTM

NDC 70000-0364-1

Medicated Hemorrhoidal Pads

WITCH HAZEL, 50% | Astringent

Provides Immediate Relief from Itching and Burning Caused by Hemorrhoids

Witch Hazel to Soothe and Protect Irritated Areas

COMPARE TO TUCKS® MEDICATED COOLING PADS active ingredient*

100% Money Back Guarantee

100 PADS

*This product is not manufactured or distributed by McNEIL-PPC, Inc., owner of the registered trademark Tucks® Medicated Cooling Pads.


* Please review the disclaimer below.