HEMORRHOIDAL COOLING- phenylephrine hcl, witch hazel gel

Hemorrhoidal cooling by

Drug Labeling and Warnings

Hemorrhoidal cooling by is a Otc medication manufactured, distributed, or labeled by Walgreens, Vi-Jon. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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 practial, 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

175.000/175AA

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)

INGREDIENTS AND APPEARANCE

HEMORRHOIDAL COOLING 
phenylephrine hcl, witch hazel gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0363-0086
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE	24.8 g  in 1 g
witch hazel (UNII: 101I4J0U34) (WITCH HAZEL - UNII:101I4J0U34)	witch hazel	497 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
SULISOBENZONE (UNII: 1W6L629B4K)
EDETATE DISODIUM (UNII: 7FLD91C86K)
HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%) (UNII: S38J6RZN16)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
water (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0363-0086-01	1 in 1 BOX	07/30/2016
1		25.5 g in 1 TUBE; Type 0: Not a Combination Product

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 (790752542)

Establishment
Name	Address	ID/FEI	Business Operations
Vi-Jon		088520668	manufacture(0363-0086)