Otc - Active Ingredient
Glycerin 14.4%, Petrolatum 15%, Phenylephrine HCl 0.25%, Pramoxine HCl 1%
Bloop Hemorrhoid Relief Topical Cream
FDA Label NDC 83838-155
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Three Nations Corp for the product Bloop Hemorrhoid Relief Topical (NDC 83838-155). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, indications & usage, warnings, otc - pregnancy or breast feeding, otc - keep out of reach of children, dosage & administration, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Anorectal (hemorrhoidal)
Indications & 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.
Warnings
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
- 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
When using this product
Otc - Pregnancy Or Breast Feeding
Ask a health professional before use.
Otc - Keep Out Of Reach Of Children
If swallowed, get medical help or contact a Poison Control Center immediately.
Dosage & 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.
Inactive Ingredient
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
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