Otc - Active Ingredient
Lidocaine 5%
Bloop Fissure Healing Anorectal Topical Cream
FDA Label NDC 83838-153
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 Fissure Healing Anorectal Topical (NDC 83838-153). 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, fissures, and other anorectal disorders
Warnings
For external use only (skin of the perianal area and anal canal).
When using this product
- 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
- condition worsens or does not improve within 7 days
- rectal bleeding occurs
- allergic reaction occurs to ingredients in this product
- symptom being treated does not subside or if redness, irritation, swelling, pain, or other symptoms develop or increase
Stop use and ask a doctor if
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 6 times a day
- Children under 12 years of age consult a doctor
Inactive Ingredient
Benzyl alcohol, carbomer, cholesterol, euterpe oleracea fruit oil, hydrogenated lecithin, isopropyl myristate, pentaclethra macroloba seed oil, polysorbate 80, propanediol, tocopheryl acetate, triethanolamine, water.
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