Hemorroidal Cooling Gel: Package Insert and Label Information

HEMORROIDAL COOLING GEL- witch hazel and phenylephrine hydrochloride gel
Chain Drug Marketing Association

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.

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

HEMORROIDAL COOLING GEL phenylephrine, witch hazel gel

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

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength WITCH HAZEL (WITCH HAZEL) WITCH HAZEL 0.5 g in 100 g PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE 0.25 g in 100 g

Inactive Ingredients Ingredient Name Strength POLYSORBATE 80 METHYLPARABEN SULISOBENZONE EDETATE DISODIUM (EDETIC ACID) ALOE VERA LEAF WATER SODIUM CITRATE PROPYLENE GLYCOL .ALPHA.-TOCOPHEROL ACETATE, D- PROPYLPARABEN HYDROXYETHYL CELLULOSE (2000 CPS AT 1%)

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:63868-483-18 1 TUBE in 1 BOX contains a TUBE 1 51 g in 1 TUBE This package is contained within the BOX (63868-483-18)

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)

Revised: 05/2023 Chain Drug Marketing Association