Active Ingredient
Phenylephrine HCI, 0.25%
Witch Hazel, 50.0%
Hemorrhoidal Cooling Gel
FDA Label NDC 49348-811
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Mckesson for the product Hemorrhoidal Cooling Gel (NDC 49348-811). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient, purpose, 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, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
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
- thyroid disease
- high blood pressure
- 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 into the rectum 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 Breastfeeding,
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: ask a doctor.
Other
Other Information
Store at room temperature: 20° - 25° C (68° - 77° F)
Inactive Ingredients
Aloe barbadensis gel, benzophenone-4, edetate disodium, hydroxyethylcellulose, methylparaben, polysorbate 80, propylene glycol, propylparaben, sodium citrate, vitamin E, water
Otc - Questions
Package Information - Tube
Sunmark®
COMPARE TO PREPARATION H® ACTIVE INGREDIENTS*
NDC 49348-811-32
Hemorrhoidal Cooling Gel
Fast Cooling Relief
WITH VITAMIN E AND ALOE
NET WT. 1.8 OZ (51 g)
This tube is sealed and packaged in a carton. Do not buy if carton is missing. Do not use if the seal under the cap has been punctured or if the tube is damaged.
Distributed by McKesson
One Post Street
San Francisco, CA 94104
Money Back Guarantee
Tube (33 50036 Sm Tb A1106)
Package Information - Carton
Sunmark®
COMPARE TO PREPARATION H® ACTIVE INGREDIENTS*
NDC 49348-811-32
Hemorrhoidal Cooling Gel
Fast Cooling Relief
Clear, non-greasy formula with no unpleasant scent
Prompt cooling relief from painful burning and itching
WITH VITAMIN E AND ALOE
NET WT. 1.8 OZ (51 g)
Another Quality Product Distributed by McKesson
One Post Street, San Francisco, CA 94104
Money Back Guarantee
Please visit us at www.sunmarkbrand.com
FOR YOUR SAFETY, TUBE IS SEALED. DO NOT USE IF TUBE SEAL UNDER CAP IS BROKEN OR MISSING.
*This product is not manufactured by Wyeth Consumer Healthcare, Inc., owner of the registered trademark Preparation H®.
Carton (33 50036 Sm C A1106)
* Please review the disclaimer below.
