Hemorrhoidal Cooling: Package Insert and Label Information

HEMORRHOIDAL COOLING- phenylephrine hydrochloride and witch hazel gel
Walgreens

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Active ingredient

Phenylephrine HCl 0.25%

Witch hazel 50%

Purpose

Vasoconstrictor

Astringent

Use

  • helps relieve the local itching and discomfort associated with hemorrhoids
  • temporary relief of irritation and burning
  • temporarily shrinks hemorrhoidal tissue
  • aids in protecting in protecting irritated anorectal areas

Warnings

For external use only

Do not use

this product if you have heart disease, high blood pressure, thyroid disease, diabetes, or difficulty in urination due to enlargement of the prostate gland unless directed by a doctor

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
  • in case of bleeding, consult a doctor promptly

stop use and ask a doctor if

condition worsens or does not improve with in 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 appropriate cleansing pad. Gently dry by patting or blotting with toilet tissue or a soft cloth before appliacation of this product
  • when you first opening the tube, remove foil under cap
  • apply externally to affected area up to 4 times daily
  • children under 12 years of age: ask a doctor

Other information

store between 15° — 30° C (58° — 86 ° F)

Inactive ingredients

Aloe barbadensis leaf juice, benzophenone-4, disodium EDTA, hydroxyethylcellulose, methylparaben, propylene glycol, propylparaben, sodium citrate, water

Questions or comments?

Call 1-888-593-0593

Pharmacist Survery

Walgreens Pharmacist Survey Study, November 2014

This product is not manufactured or distributed by Pfizer Consumer Health care, distributor of Preparation H Hemorrhidal Cooling Gel.

Adverse Reactions Section

DISTRIBUTED BY: WALGREEN CO.

200 WILMOT RD., DEERFIELD, IL 60015

WALLGREENS 100% SATISFACTION GUARANTEED

walgreens.com

principal display panel

Well at

Walgreens

Hemorrhoidal Cooling Gel

Quick, Cooling Relief/With Soothing Aloe

  • Clear, non-greasy formula, with no unpleasant scent
  • Temporarily shrinks swollen hemorrhoidal tissue
  • Quick, cooling relief from burning & itching
  • Temporarily relieves irritation

Compare to Preparathion H Hemorrhoidal Cooling Gel active ingredients

NET WT 0.9 OZ (25.5 g)

image description
(click image for full-size original)
HEMORRHOIDAL COOLING
phenylephrine hcl, witch hazel gel
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0363-0086
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE 24.8 g in 1 g
witch hazel (WITCH HAZEL) witch hazel 497 g in 1 g
Inactive Ingredients
Ingredient Name Strength
ALOE VERA LEAF
SULISOBENZONE
EDETATE DISODIUM
HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%)
METHYLPARABEN
PROPYLENE GLYCOL
PROPYLPARABEN
SODIUM CITRATE
water
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0363-0086-01 1 TUBE in 1 BOX contains a TUBE
1 25.5 g in 1 TUBE This package is contained within the BOX (0363-0086-01)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part346 07/30/2016
Labeler — Walgreens (008965063)
Registrant — Vi-Jon, LLC (790752542)
Establishment
Name Address ID/FEI Operations
Vi-Jon, LLC 088520668 manufacture (0363-0086)
Establishment
Name Address ID/FEI Operations
Vi-Jon, LLC 790752542 manufacture (0363-0086)

Revised: 04/2022 Walgreens

DrugInserts.com provides trustworthy package insert and label information about marketed drugs as submitted by manufacturers to the US Food and Drug Administration. Package information is not reviewed or updated separately by DrugInserts.com. Every individual package label entry contains a unique identifier which can be used to secure further details directly from the US National Institutes of Health and/or the FDA.

As the leading independent provider of trustworthy medication information, we source our database directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. Our material is not intended as a substitute for direct consultation with a qualified health professional.

Terms of Use | Copyright © 2022. All Rights Reserved.