HEMORRHOIDAL COOLING GEL- phenylephrine and witch hazel gel

Hemorrhoidal Cooling Gel by

Drug Labeling and Warnings

Hemorrhoidal Cooling Gel by is a Otc medication manufactured, distributed, or labeled by McKesson. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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.

SPL UNCLASSIFIED SECTION

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

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®.

INGREDIENTS AND APPEARANCE

HEMORRHOIDAL COOLING GEL 
phenylephrine and witch hazel gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49348-811
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	0.25 g  in 1 g
WITCH HAZEL (UNII: 101I4J0U34) (WITCH HAZEL - UNII:101I4J0U34)	WITCH HAZEL	50 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
SULISOBENZONE (UNII: 1W6L629B4K)
EDETATE DISODIUM (UNII: 7FLD91C86K)
HYDROXYETHYL CELLULOSE (2000 CPS AT 1%) (UNII: S38J6RZN16)
METHYLPARABEN (UNII: A2I8C7HI9T)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49348-811-32	1 in 1 BOX
1		51 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part346	11/15/2006

Labeler - McKesson (177667227)