Megababe Butt Stuff Hemorrhoidal Ointment
FDA Label NDC 84000-502

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Megababe, Llc for the product Megababe Butt Stuff Hemorrhoidal (NDC 84000-502). 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 drug facts, active ingredients, purposes, uses:, warnings:, do not, ask a doctor or pharmacist before use if you are, when using this product, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Drug Facts

Active Ingredients

Cocoa Butter 12.5%

Glycerin 25%

Lidocaine 5%

Petrolatum 12.5%

Phenylephrine HCL 0.25%

Purposes

Protectant

Local Anesthetic

Vasoconstrictor

Uses:

  • Helps relieve the local itching and discomfort in the perianal area.
  • Temporarily relieves pain, irritation or burning and reduces the swelling associated with irritated hemorrhoidal tissue and other anorectal disorders.

Warnings:

For external use only.

Allergy alert • Certain persons can develop allergic reactions to ingredients in this product.

Do Not

  • Exceed the recommended daily dosage unless directed by a doctor.
  • Put this product into the rectum by using fingers or any mechanical device or applicator.
  • Use this product if you have heart disease, high blood pressure, thyroid disease, diabetes, or difficulty in urination due to enlargement of the prostate gland unless directed by a doctor.

Ask A Doctor Or Pharmacist Before Use If You Are

  • Presently taking a prescription drug for high blood pressure or depression.

When Using This Product

  • If condition worsens or does not improve within 7 days, consult a doctor.
  • In case of bleeding, consult a doctor promptly.

Stop Use And Ask A Doctor If

  • If the symptom being treated does not subside or if redness, irritation, swelling, pain, or other symptoms develop or increase.

Keep Out Of Reach Of Children.

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

If Pregnant Or Breastfeeding,

ask a health professional before use.

Directions:

Adults: • When practical, cleanse the affected area with mild soap and warm water and rinse by patting or blotting with an appropriate cleansing pad.

  • Gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product.
  • Children under 12 years of age: consult a doctor.
  • Apply externally to the affected area up to 4 times daily.

Other Information:

Store at room temperature and away from direct sunlight. Do not use if tamper seal over the tube opening is missing.

Inactive Ingredients:

Aloe Barbadensis Leaf Juice, Aqua (Deionized Water), Ascorbic Acid (Vitamin C), Behentrimonium Methosulfate, Butyrospermum Parkii (Shea) Butter, Calendula Officinalis Extract, Caprylyl Glycol, Carbomer, Cetearyl Alcohol, Cetyl Alcohol, Cocos Nucifera (Coconut) Oil, Colloidal Oatmeal, Cucumis Sativus Extract, Decyl Glucoside, Dimethicone, Glyceryl Laurate, Glyceryl Stearate, Glyceryl Undecylenate, Glycyrrhiza Glabra (Licorice) Root Extract, Hamamelis Virginiana (Witch Hazel) Water, Helianthus Annuus (Sunflower) Seed Oil, Persea Gratissima (Avocado) Oil, Polysorbate 20, Stearic Acid, Stearyl Alcohol, Tetrasodium EDTA, Tocopheryl Acetate (Vitamin E), Xanthan Gum, Propanediol.

* Please review the disclaimer below.