FDA Label for Preferred Plus Hemorrhoidal

View Indications, Usage & Precautions

Preferred Plus Hemorrhoidal Product Label

The following document was submitted to the FDA by the labeler of this product Kinray Inc.. 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.

Other



Drug Facts


Active Ingredients



Phenylephrine hydrochloride 0.25%

Witch hazel 50.0%


Otc - Purpose



Vasoconstrictor

Astringent


Uses



  • temporarily relieves irritation and burning
  • helps relieve the local itching and discomfort associated with hemorrhoids
  • temporarily shrinks hemorrhoidal tissue
  • aids in protecting irritated anorectal areas

Warnings



For external use only


Ask A Doctor Before Use If You Have



  • heart disease
  • high blood pressure
  • diabetes
  • thyroid disease
  • trouble urinating due to an enlarged prostate gland

Otc - Ask Doctor/Pharmacist



Ask a doctor or pharmacist before use if you are presently taking a prescription drug for high blood pressure or depression


When Using This Product



  • do not exceed the recommended daily dosage
  • do not put this product into the rectum by using fingers or any mechanical device or applicator

Stop Use And Ask A Doctor If



  • bleeding occur
  • condition gets worse or does not Improve within 7 days

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.


Directions



  • Adults: when practical, cleanse and gently dry the affected area by patting or blotting with an appropriate cleansing tissue or soft cloth before applying gel
  • when first opening the tube, puncture foil seal with top end of cap
  • apply externally to the affected area up to 4 times daily, especially at night, in the morning or after each bowel movement
  • Children under 12 years of age: ask a doctor

Other Information



  • store at 20°-25°C (68°-77°F)
  • for lot number and expiration date, see crimp of tube or see box

Inactive Ingredients



  • aloe barbadensis leaf juice, disodium EDTA, hydroxyethylcellulose, methylparaben, polysorbate 80, propylene glycol, propylparaben, purified water, sodium citrate, tocopheryl acetate (Vitamin E)

Principal Display Panel - 1 Oz Carton Label



TAMPER-EVIDENT: Do not use if printed "safety sealed" overwrap is broken or missing.

NDC 61715-093-01

Preferred Plus Pharmacy®

HEMORRHOIDAL

Cooling Gel with aloe

*Compare to the active ingredients in PREPARATION H® Cooling Gel

Fast Cooling Relief

  • Clean, Non-Greasy Formula with No Unpleasant Scent
  • Prompt Cooling Relief from Painful Burning and Itching
  • Shrinks Swollen Hemorrhoidal Tissue
  • Relieves External Discomfort
  • SATISFACTION GUARANTEED

    Preferred Plus Pharmacy®

    NET WT 1 OZ (28 g)


* Please review the disclaimer below.