HEMORROIDAL COOLING GEL- phenylephrine, witch hazel gel

Hemorroidal Cooling gel by

Drug Labeling and Warnings

Hemorroidal Cooling gel by is a Otc medication manufactured, distributed, or labeled by Chain Drug Marketing Association, Trifecta Pharmaceuticals USA. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredient

Phenylephrine HCI 0.25%

Purpose

Vasoconstrictor

Active Ingredient

Witch Hazel 50%

Purpose

Astringent

Uses

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

Stop use and ask a doctor

• bleeding occurs
• condition worsens or does not improve within 7 days

If pregnant or breast feeding

Ask a doctor before use

Keep out of the reach of children

If swallowed get medical help or contact Poison Control Center right away

Directions

Children under 12 years of age; ask a doctor before use

Adults: when practical, clean 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
• when first opening tube, remove foil seal
• apply externally to the affected area up to 4 times daily, especially at night, in the morning or after each bowel movement

Warnings

For External Use Only

Ask doctor before use if you have

• heart disease
• high blood pressure
• thyroid disease
• diabetes
• difficulty urinating due to an enlarged prostate gland

Ask doctor 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 by using fingers or any mechanical device or applicator

Other information

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

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

Inactive Ingredients

Aloe barbadensis gel, benzophenone-4, Acetate disodium, Hydroxyethylcellulose, methylparaben, polysorbate 80, propylene glycol, propylparaben, sodium citrate, Vitamin E, water

Questions or Comments

Call Toll Free 1-800-935-2362

Distributed by

C.D.M.A. Inc. ©

43157 W 9 Mile Rd.

Novi, MI. 48375 USA

1-800-935-2362

www.qualitychoice.com

Product of PRC

Packaging

Packaging

INGREDIENTS AND APPEARANCE

HEMORROIDAL COOLING GEL 
phenylephrine, witch hazel gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63868-483
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
WITCH HAZEL (UNII: 101I4J0U34) (WITCH HAZEL - UNII:101I4J0U34)	WITCH HAZEL	0.5 g  in 100 g
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	0.25 g  in 100 g

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63868-483-18	1 in 1 BOX	07/15/2019
1		51 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	07/15/2019

Labeler - Chain Drug Marketing Association (011920774)

Registrant - Trifecta Pharmaceuticals USA (079424163)