NDC 49348-811 Hemorrhoidal Cooling Gel

Product Information

What is NDC 49348-811?

The NDC code 49348-811 is assigned by the FDA to the product Hemorrhoidal Cooling Gel which is product labeled by Mckesson. The product's dosage form is and is administered via form. The product is distributed in a single package with assigned NDC code 49348-811-32 1 tube in 1 box / 51 g in 1 tube. This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information, RxNorm crosswalk and the complete product label.

NDC Product Code49348-811
Proprietary Name What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
Hemorrhoidal Cooling Gel
Product Labeler Information What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.
Mckesson
Labeler Code49348
Start Marketing Date What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.
11-15-2006
Listing Expiration Date What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.
12-31-2017
Exclude Flag What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".
I
NDC Code Structure

What are the uses for Hemorrhoidal Cooling Gel?


Product Packages

NDC Code 49348-811-32

Package Description: 1 TUBE in 1 BOX / 51 g in 1 TUBE

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Product Details

Hemorrhoidal Cooling Gel Active Ingredients UNII Codes

NDC to RxNorm Crosswalk

What is RxNorm? RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:
  • RxCUI: 249465 - phenylephrine HCl 0.25 % / witch hazel 50 % Rectal Gel
  • RxCUI: 249465 - phenylephrine 0.0025 MG/MG / witch hazel 0.5 MG/MG Rectal Gel
  • RxCUI: 249465 - phenylephrine 0.25 % / witch hazel 50 % Rectal Gel

Hemorrhoidal Cooling Gel Inactive Ingredients UNII Codes

The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

* Please review the disclaimer below.

Hemorrhoidal Cooling Gel Product Label

FDA filings in the form of structured product labels are documents that include all published material associated whith this product. Product label information includes data like indications and usage generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Label Table of Contents



Active Ingredient



Phenylephrine HCI, 0.25%
Witch Hazel, 50.0%


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


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®.




* Please review the disclaimer below.