FDA Label for Hemorrhoidal Anesthetic

View Indications, Usage & Precautions

Hemorrhoidal Anesthetic Product Label

The following document was submitted to the FDA by the labeler of this product Purity Products. 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


Otc - Purpose



Active IngredientsPurposes
Glycerin 14.4%Protectant
Phenylephrine HCl 0.25%Vasoconstrictor
Pramoxine HCl 1%Local Anesthetic
White petrolatum 15%Protectant

Uses



  • For temporary relief of pain, soreness and burning
  • Helps relieve the local itching and discomfort associated with hemorrhoids
  • Temporarily shrinks hemorrhoidal tissue and relieves burning
  • Temporarily provides a coating for relief of anorectal discomforts
  • Temporarily protects the inflamed, irritated anorectal surface to help make bowel movements less painful

Warnings



For external use only


Ask A Doctor Before Use If You Have



  • Heart disease
  • High blood pressure
  • Thyroid disease
  • Diabetes
  • Difficulty urinating due to enlargement of the prostate gland

Otc - Ask Doctor/Pharmacist



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


When Using This Product



  • Do not exceed the recommended daily dosage unless directed by a doctor
  • Do not put into the rectum by using fingers or any mechanical device or applicator

Stop Use And Ask A Doctor If



  • Bleeding occurs the condition worsens or does not improve within 7 days
  • An allergic reaction develops
  • The symptom being treated does not subside or if redness, irritation, swelling, pain or other symptoms develop or increase

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 the affected area by patting or blotting with an appropriate cleansing wipe. Gently dry by patting or blotting with a tissue or soft cloth before applying the cream
  • When first opening the tube, remove the foil seal
  • Apply externally or in the lower portion of the anal canal only
  • Apply externally to the affected area up to 4 times daily, especially at night, in the morning, or after each bowel movement
  • For application in the lower anal canal; remove the cover from the dispensing cap. Attach the dispensing cap to the tube. Lubricate the dispensing cap well, then gently insert the dispensing cap partway into the anus.
  • Thoroughly cleanse the dispensing cap after each use, and replace the cover
  • Children under 12 years: ask a doctor

Other Information



  • Store at 15 to 30°C (59 to 86°F)

Inactive Ingredient



Aloe barbadensis leaf extract, anhydrous citric acid, butylated hydroxyanisole, cetyl alcohol, edetate disodium, glyceryl monostearate, laureth-23, methylparaben, mineral oil, panthenol, propyl gallate, propylene glycol, propylparaben, purified water, sodium benzoate, sodium carboxymethyl cellulose, steareth-2, steareth-20, stearyl alcohol, vitamin E acetate, xanthan gum


Questions Or Comments?



To Reorder Call: 1-800-281-7781, Customer Care: 1-888-769-7873 or www.purityproducts.com


Principal Display Panel - 25.5 G Tube Carton



NET WT.
0.9 OZ (25.5 G)

Save
Uranus

RAPID
SOOTHING

Relief & Comfort

MAXIMUM STRENGTH FOR PAINFUL
BURNING, ITCHING, & DISCOMFORT.


* Please review the disclaimer below.