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 Amerisource Bergen. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Phenylephrine HCI, 0.25%
Witch Hazel, 50%

PURPOSE

Vasoconstrictor
Astringent

USES

• Helps relieve the local itching and discomfort associated with hemorrhoids
• Temporary relief of itching 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
  

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

GOOD NEIGHBOR PHARMACY

NDC: 24385-421-06

HEMORRHOIDAL
Cooling Gel
with Vitamin E and Aloe

Fast cooling relief from painful burning and itching

Net Wt. 0.9 oz. (26 g)

Fast cooling relief

• Clear, non-greasy formula with no unpleasant scent
• Prompt cooling relief from painful burning and itching
• Shrinks swollen hemorrhoidal tissue 
• Relieves external discomfort
  

*Compare to active ingredients in Preparation H® Cooling Gel


FOR YOUR SAFETY, TUBE IS SEALED. DO NOT USE IF TUBE SEAL UNDER CAP IS BROKEN OR MISSING.

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

Distributed By
AmerisourceBergen
Valley Forge, PA 19482-0959

Visit us at www.myGNP.com

INGREDIENTS AND APPEARANCE

HEMORRHOIDAL COOLING GEL 
phenylephrine and witch hazel gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 24385-421
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: 24385-421-06	1 in 1 BOX
1		26 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part346	08/01/2006

Labeler - Amerisource Bergen (007914906)