FDA Label for Preparation H Rapid Relief
View Indications, Usage & Precautions
- ACTIVE INGREDIENTS
- PURPOSES
- INDICATIONS & USAGE
- WARNINGS
- ASK A DOCTOR BEFORE USE IF YOU HAVE
- OTC - ASK DOCTOR/PHARMACIST
- WHEN USING THIS PRODUCT
- STOP USE AND ASK A DOCTOR IF
- OTC - PREGNANCY OR BREAST FEEDING
- OTC - KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- STORAGE AND HANDLING
- INACTIVE INGREDIENT
- OTC - QUESTIONS
- ADDITIONAL INFORMATION
- PRINCIPAL DISPLAY PANEL
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
• Rapid numbing relief of pain,itching and burning
• Reduces swelling of
inflamed tissue• Highest strength lidocaineavailable
NET WT 3.8 OZ (107.7 g)
000070918 Front Label
* Please review the disclaimer below.