FDA Label for Preparation H Cooling Gel
View Indications, Usage & Precautions
- ACTIVE INGREDIENTS
- PURPOSES
- USES
- WARNINGS
- ASK A DOCTOR BEFORE USE IF YOU HAVE
- ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
- WHEN USING THIS PRODUCT
- STOP USE AND ASK A DOCTOR IF
- IF PREGNANT OR BREAST-FEEDING,
- KEEP OUT OF REACH OF CHILDREN.
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS OR COMMENTS?
- PRODUCT PACKAGING
Preparation H Cooling Gel 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
Phenylephrine HCl 0.25%
Witch hazel 50.0%
Purposes
Vasoconstrictor
Astringent
Uses
- helps relieve the local itching and discomfort associated with hemorrhoids
- temporary relief of irritation and burning
- 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
- thyroid disease
- diabetes
- difficulty in urination due to enlargement of the prostate gland
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
Stop Use And Ask A Doctor If
- bleeding occurs
- condition worsens or does not improve within 7 days
If Pregnant Or Breast-Feeding,
ask a health professional before use.
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 a 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)
Inactive Ingredients
aloe barbadensis leaf juice, edetate disodium, hydroxyethyl cellulose, methylparaben, polysorbate 80, propylene glycol, propylparaben, purified water, sodium citrate, sulisobenzone, vitamin E acetate
Questions Or Comments?
Call weekdays 9 AM to 5 PM EST at 1-800-99PrepH or 1-800-997-7374.
Product Packaging
The product packaging shown below represents a sample of that currently in use. Additional packaging may also be available.
PREPARATION H HEMORRHOIDAL Cooling Gel
Fast Cooling Relief
Clear, Non-Greasy Formula with No Unpleasant Scent
Prompt Cooling Relief from Painful Burning and Itching
Shrinks Swollen Hemorrhoidal Tissue
Relieves External Discomfort
NET WT 1.8 OZ (51g)
Do Not Use if tube seal under cap embossed with “H” is broken or missing.
For most recent product information, visit www.preparationh.com
Wyeth Consumer Healthcare
Madison, NJ 07940 USA ©2009 Wyeth
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