Glycerin, Phenylephrine Hydrochloride, Pramoxine, White Petrolatum
FDA Label NDC 11673-572

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Target Corporation for the product Glycerin, Phenylephrine Hydrochloride, Pramoxine, White Petrolatum (NDC 11673-572). 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 ingredients, purpose, uses, 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, warnings, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients

Glycerin, USP 14.4%Phenylephrine HCI, 0.25%Pramoxine HCI, 1%White petrolatum, 15%

Purpose

Protectant

Vasoconstrictor

Local anesthetic

Protectant

Uses

  • Temporarily relieves 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

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

Stop Use And Ask A Doctor If

  • bleeding occurs
  • the introduction of the applicator causes additional pain
  • 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

Warnings


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 soft cloth before applying cream.
  • When first opening the tube, puncture foil seal with top end of cap
  • Apply externally or in the lower portion of the anal canal only
  • Apply externally to the affected area up to 4 times daily, especially at night, in the morning or after each bowel movement
  • For application in the lower anal canal: remove cover from dispensing cap. Attach dispensing cap to tube. Lubricate applicator well, then gently insert applicator into the rectum.
  • Thoroughly clean dispensing cap after each use and replace cover
    • Children under 12 years:  ask a doctor.

Other


Other Information

Store at room temperature: 20° - 25° C (68° - 77° F)

Inactive Ingredients

Aloe barbadensis leaf extract, BHA, carboxymethylcellulose sodium, cetyl alcohol, citric acid, edetate disodium, glyceryl stearate, laureth-23, methylparaben, mineral oil, panthenol, propyl gallate, propylene glycol, propylparaben, purified water, sodium benzoate, steareth-2, steareth-20, stearyl alcohol, tocopherol. vitamin E, xanthan gum

Questions?

Call 1-800-910-6874

Package Information - Tube

Up and upNDC 11673-572-24Hemorrhoidal Creammaximum strengthCompare to Preparation H® Hemorrhoidal Cream*Helps shrink swelling of irritated hemorrhoidal tissuesNET 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.*This product is not manufactured or distributed by Wyeth Consumer Healthcare, owner of the registered trademark Preparation H®.Dist. by Target Corp.Minneapolis, MN 55403Made in U.S.A.® and © 2009 Target Brands, Inc.All Rights ReservedShop Target.com

Package Information - Box

up and up

NDC 11673-572-24

Hemorrhoidal Cream
maximum strength

Compare to Preparation H® Hemorrhoidal Cream*

Helps shrink swelling of irritated hemorrhoidal tissues

NET WT 1.8 OZ (51 g)

DO NOT USE IF SEAL UNDER CAP OF TUBE IS BROKEN OR MISSING WHEN PURCHASED.

*This product is not manufactured or distributed by Wyeth Consumer Healthcare, owner of the registered trademark Preparation H®.

Distributed by Target Corporation
Minneapolis, MN 55403
Made in U.S.A.

® and © 2009 Target Brands, Inc.
All Rights Reserved
Shop Target.com



Box (33 4012ta C A0409)

Box (33 4012ta C A0409)

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