FDA Label for Megababe Butt Stuff Hemorrhoidal

View Indications, Usage & Precautions

Megababe Butt Stuff Hemorrhoidal Product Label

The following document was submitted to the FDA by the labeler of this product Megababe, Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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.


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