FDA Label for Preparation H Rapid Relief

View Indications, Usage & Precautions

Preparation H Rapid Relief Product Label

The following document was submitted to the FDA by the labeler of this product Haleon Us Holdings Llc. 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 Ingredients



Lidocaine 5%

Phenylephrine HCl 0.25%


Purposes



Local anesthetic

Vasoconstrictor


Indications & Usage



Uses

  • •Helps relieve the local discomfort and itching associated with hemorrhoids
  • •For the temporary relief of pain, soreness or burning
  • •Temporarily reduces the swelling associated with irritation in hemorrhoids
  • •Temporarily shrinks hemorrhoidal tissue

Warnings



Warnings

For external use only

Flammable: Do not use while smoking or near heat or flame


Ask A Doctor Before Use If You Have



  • •heart disease
  • •high blood pressure
  • •thyroid disease
  • •diabetes
  • •difficulty in urination due to enlargement of the 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 unless directed by a doctor
  • •do not put this product into the rectum by using fingers or any mechanical device or applicator
  • Warning - avoid spraying in eyes. Contents under pressure. Do not puncture or incinerate. Do not store at temperature above 120°F. Keep out of reach of children.
  • Warning - use only as directed. Intentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal.

Stop Use And Ask A Doctor If



  • •bleeding occurs
  • •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.


Dosage & Administration



Directions

  • •Adults: when practical, cleanse the affected area by patting or blotting with an appropriate cleansing pad
  • •Gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product
  • •Shake well before using
  • •Hold 3 to 6” away from rectal area, spray to moisten and then wipe off excess, if desired
  • •Apply externally to the affected area up to 4 times daily
  • •Children under 12 years of age: consult a doctor

Storage And Handling



Other information

  • •Store at 20-25°C (68-77°F)

Inactive Ingredient



Inactive ingredients

aloe barbadensis leaf juice, citric acid, disodium EDTA, glycerin, isobutane, malic acid, menthol, propyl gallate, propylene glycol, SD alcohol 40-B, sodium benzoate, water


Otc - Questions



Questions or comments?

Call weekdays 9 AM to 5 PM EST at 1-800-99PrepH or 1-800-997-7374


Additional Information



No-Touch Spray

Do not use if clear safety seal around cap is broken or missing

Distributed by:

GSK Consumer Healthcare

Warren, NJ 07059

Trademarks are owned by or licensed to the GSK group of companies.

@2021 GSK or licensor

For most recent product information, visit www.preparationh.com


Principal Display Panel



NEW!

PREPARATIONH

RAPID RELIEF
WITH
LIDOCAINE

HEMORRHOIDAL SPRAY

LIDOCAINE
PHENYLEPHRINE HCl

* Please review the disclaimer below.