Bloop Hemorrhoid Relief Topical Cream

Bloop Hemorrhoid Relief Topical Cream
SPL v1
SPL
SPL Set ID 0b6419e3-f1c7-bdfe-e063-6294a90a5d92
Route
TOPICAL
Published
Effective Date 2023-11-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Glycerin (14.4 g) Pramoxine (1 g) Petrolatum (15 g) Phenylephrine Hydrochloride, (+/-)- (0.25 g)
Inactive Ingredients
Cetostearyl Alcohol Benzyl Alcohol Copaifera Officinalis Resin Glyceryl Stearate Se Edetate Disodium Ethylhexylglycerin Propanediol Cetyl Alcohol Steareth-21 Carapa Guianensis Seed Oil Stearyl Alcohol Water Mineral Oil Tocopherol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-11-14

Description

Glycerin 14.4%, Petrolatum 15%, Phenylephrine HCl 0.25%, Pramoxine HCl 1%


Medication Information

Warnings and Precautions

For external use only (skin of the perianal area and anal canal).

Ask a doctor before use if you have

  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • difficulty in urination due to enlargement of the prostate gland
  • presently taking a prescription drug for high blood pressure or depression

When using this product

  • avoid contact with eyes
  • do not exceed recommended dosage unless directed by a doctor
  • do not put this product into the rectum by using fingers or any mechanical device or applicator
Indications and Usage
  • Helps relieve the pain, itching, and burning associated with hemorrhoids and other anorectal disorders
  • Temporarily protects the inflamed, irritated anorectal surface to help make bowel movements less painful from irritation and abrasion during bowel movement.
  • Temporarily shrinks hemorrhoidal tissue.
Dosage and Administration
  • Gently dry by patting or blotting with toilet tissue or soft cloth before applying
  • Carefully apply medication to the perianal skin and anal canal with a clean finger
  • Adults and children 12 years and older: apply externally to the affected area up to 4 times daily, especially at night, in morning or after bowel movement
  • Children under 12 years of age consult your pediatrician.
Description

Glycerin 14.4%, Petrolatum 15%, Phenylephrine HCl 0.25%, Pramoxine HCl 1%

Section 50565-1

If swallowed, get medical help or contact a Poison Control Center immediately.

Section 51727-6

Benzyl alcohol, carapa guianensis seed oil, cetearyl alcohol, cetyl alcohol, copaifera officinalis (balsam copaiba) resin, disodium EDTA, ethylhexylglycerin, glyceryl stearate SE, mineral oil, propanediol, steareth-21, stearyl alcohol, tocopherol, water

Section 51945-4

Section 53414-9

Ask a health professional before use.

Section 55105-1

Anorectal (hemorrhoidal)

Section 55106-9

Glycerin 14.4%, Petrolatum 15%, Phenylephrine HCl 0.25%, Pramoxine HCl 1%


Structured Label Content

Indications and Usage (34067-9)
  • Helps relieve the pain, itching, and burning associated with hemorrhoids and other anorectal disorders
  • Temporarily protects the inflamed, irritated anorectal surface to help make bowel movements less painful from irritation and abrasion during bowel movement.
  • Temporarily shrinks hemorrhoidal tissue.
Dosage and Administration (34068-7)
  • Gently dry by patting or blotting with toilet tissue or soft cloth before applying
  • Carefully apply medication to the perianal skin and anal canal with a clean finger
  • Adults and children 12 years and older: apply externally to the affected area up to 4 times daily, especially at night, in morning or after bowel movement
  • Children under 12 years of age consult your pediatrician.
Warnings and Precautions (34071-1)

For external use only (skin of the perianal area and anal canal).

Ask a doctor before use if you have

  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • difficulty in urination due to enlargement of the prostate gland
  • presently taking a prescription drug for high blood pressure or depression

When using this product

  • avoid contact with eyes
  • do not exceed recommended dosage unless directed by a doctor
  • do not put this product into the rectum by using fingers or any mechanical device or applicator
Section 50565-1 (50565-1)

If swallowed, get medical help or contact a Poison Control Center immediately.

Section 51727-6 (51727-6)

Benzyl alcohol, carapa guianensis seed oil, cetearyl alcohol, cetyl alcohol, copaifera officinalis (balsam copaiba) resin, disodium EDTA, ethylhexylglycerin, glyceryl stearate SE, mineral oil, propanediol, steareth-21, stearyl alcohol, tocopherol, water

Section 51945-4 (51945-4)

Section 53414-9 (53414-9)

Ask a health professional before use.

Section 55105-1 (55105-1)

Anorectal (hemorrhoidal)

Section 55106-9 (55106-9)

Glycerin 14.4%, Petrolatum 15%, Phenylephrine HCl 0.25%, Pramoxine HCl 1%


Advanced Ingredient Data


Raw Label Data

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