Hemorrhoidal Cooling Gel

Hemorrhoidal Cooling Gel
SPL v4
SPL
SPL Set ID 7276aab8-0297-2a55-e053-2a91aa0a8d21
Route
TOPICAL
Published
Effective Date 2018-08-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Witch Hazel (0.5 g) Phenylephrine (0.25 g)
Inactive Ingredients
Polysorbate 80 Methylparaben Sulisobenzone Edetic Acid Aloe Vera Leaf Water Sodium Citrate Propylene Glycol .alpha.-tocopherol Acetate, D- Propylparaben Hydroxyethyl Cellulose (2000 Cps At 1%)

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2018-08-02

Description

Phenylephrine HCI 0.25%

Purpose

Vasoconstrictor


Medication Information

Purpose

Vasoconstrictor

Description

Phenylephrine HCI 0.25%

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
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
Packaging

Hemorrhoidal Cooling Gel

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
Distributed By

Premier Value Alliance, LLC.

407 East Lancaster Avenue

Wayne, PA. 19087 USA

Product of PRC

Active Ingredient

Phenylephrine HCI 0.25%

Other Information

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

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®

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 1-888-296-9067

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


Structured Label Content

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
Purpose

Vasoconstrictor

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
Packaging

Hemorrhoidal Cooling Gel

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
Distributed By

Premier Value Alliance, LLC.

407 East Lancaster Avenue

Wayne, PA. 19087 USA

Product of PRC

Active Ingredient

Phenylephrine HCI 0.25%

Other Information (Other information)

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

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®

Inactive Ingredients

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

Questions Or Comments (Questions or Comments)

Call Toll Free 1-888-296-9067

Stop Use and Ask A Doctor (Stop use and ask a doctor)
  • bleeding occurs
  • condition worsens or does not improve within 7 days
If Pregnant Or Breast Feeding (If pregnant or breast feeding)

Ask a doctor before use

Keep Out of the Reach of Children (Keep out of the reach of children)

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


Advanced Ingredient Data


Raw Label Data

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