FDA Label for Preparation H Rapid Relief
View Indications, Usage & Precautions
- OTHER
- OTC - PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- OTC - ASK DOCTOR
- OTC - ASK DOCTOR/PHARMACIST
- OTC - WHEN USING
- OTC - STOP USE
- OTC - PREGNANCY OR BREAST FEEDING
- OTC - KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- STORAGE AND HANDLING
- INACTIVE INGREDIENT
- OTC - QUESTIONS
- PRINCIPAL DISPLAY PANEL - 23 G TUBE LABEL
- PRINCIPAL DISPLAY PANEL - 23 G TUBE CARTON
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.
Other
Drug Facts
Otc - Purpose
Active ingredients | Purposes |
---|---|
Glycerin 14.4% | Protectant |
Lidocaine 5% | Local anesthetic |
Phenylephrine HCl 0.25% | Vasoconstrictor |
White petrolatum 15% | Protectant |
Indications & Usage
Uses
- for temporary relief of pain, soreness and burning
- helps relieve the local itching and discomfort associated with hemorrhoids
- temporarily shrinks hemorrhoidal tissue
- temporarily provides a coating for relief of anorectal discomforts
- temporarily protects the inflamed irritated anorectal surface to help make bowel movements less painful
Warnings
Warnings
For external use only
Otc - Ask Doctor
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.
Otc - When Using
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
Otc - Stop Use
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 wipe. Gently dry by patting or blotting with a tissue or a soft cloth before applying this cream.
- 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
Storage And Handling
Other information
store at 20-25°C (68-77°F)
Inactive Ingredient
Inactive ingredients
aloe barbadensis leaf extract, anhydrous citric acid, butylated hydroxyanisole, carboxymethylcellulose sodium, cetyl alcohol, citric acid monohydrate, dexpanthenol, edetate disodium, glyceryl monostearate, methylparaben, mineral oil, polyoxyl lauryl ether, polyoxyl stearyl ether, propyl gallate, propylene glycol, propylparaben, purified water, sodium benzoate, stearyl alcohol, tocopherols excipient, vitamin E acetate, xanthan gum
Otc - Questions
Questions or comments?
Call weekdays 9 AM to 5 PM EST at 1-800-99PrepH or 1-800-997-7374
Principal Display Panel - 23 G Tube Label
To open: push down on cap while turning counterclockwise.
Child-Resistant Cap
PREPARATION H®
HEMORRHOIDAL CREAM
RAPID RELIEF
WITH LIDOCAINE
- Rapid numbing relief of pain, itching & burning
- Reduces swelling & provides a soothing
protective layer
NET WT 0.75 OZ (23g)
Principal Display Panel - 23 G Tube Carton
PREPARATION H®
New Benefit
Now Reduces Swelling
See new label
RAPID RELIEF
WITH
LIDOCAINE
HEMORRHOIDAL
CREAM
LIDOCAINE
PHENYLEPHRINE HCl
GLYCERIN
WHITE PETROLATUM
5%
HIGHEST STRENGTH
LIDOCAINE
AVAILABLE
- Rapid numbing relief of pain,
itching & burning - Reduces swelling & provides
a soothing protective layer
1 TUBE | NET WT 0.75 OZ (23 g)
* Please review the disclaimer below.