Megababe Butt Stuff Hemorrhoidal Ointment

Megababe Butt Stuff Hemorrhoidal Ointment
SPL v1
SPL
SPL Set ID 01c156ff-69f9-4d5e-a9ea-abbc52d4afff
Route
TOPICAL
Published
Effective Date 2024-06-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Cocoa Butter (125 mg) Glycerin (250 mg) Lidocaine (50 mg) Petrolatum (2.5 mg) Phenylephrine
Inactive Ingredients
Aloe Vera Leaf Water Ascorbic Acid Behentrimonium Methosulfate Shea Butter Calendula Officinalis Flower Caprylyl Glycol Carbomer Homopolymer, Unspecified Type Cetostearyl Alcohol Coconut Oil Oatmeal Decyl Glucoside Dimethicone Glyceryl Laurate Glyceryl Monostearate Glycyrrhiza Glabra Hamamelis Virginiana Top Water Sunflower Oil Avocado Oil Polysorbate 20 Stearic Acid Stearyl Alcohol Edetate Sodium .alpha.-tocopherol Acetate Xanthan Gum Propanediol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-06-06

Description

Cocoa Butter 12.5% Glycerin 25% Lidocaine 5% Petrolatum 12.5% Phenylephrine HCL 0.25%

Purpose

Protectant Local Anesthetic Vasoconstrictor


Medication Information

Purpose

Protectant Local Anesthetic Vasoconstrictor

Description

Cocoa Butter 12.5% Glycerin 25% Lidocaine 5% Petrolatum 12.5% Phenylephrine HCL 0.25%

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.
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.
Purposes

Protectant

Local Anesthetic

Vasoconstrictor

Warnings:

For external use only.

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

Drug Facts

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.
Package Labeling:

Active Ingredients

Cocoa Butter 12.5%

Glycerin 25%

Lidocaine 5%

Petrolatum 12.5%

Phenylephrine HCL 0.25%

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.

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.
If Pregnant Or Breastfeeding,

ask a health professional before use.

Keep Out of Reach of Children.

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

Ask A Doctor Or Pharmacist Before Use If You Are
  • Presently taking a prescription drug for high blood pressure or depression.

Structured Label Content

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.
Do Not (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.
Purposes

Protectant

Local Anesthetic

Vasoconstrictor

Warnings:

For external use only.

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

Drug Facts

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.
Package Labeling:

Active Ingredients (Active ingredients)

Cocoa Butter 12.5%

Glycerin 25%

Lidocaine 5%

Petrolatum 12.5%

Phenylephrine HCL 0.25%

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.

When Using This Product (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 (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.
If Pregnant Or Breastfeeding, (If pregnant or breastfeeding,)

ask a health professional before use.

Keep Out of Reach of Children. (Keep out of reach of children.)

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

Ask A Doctor Or Pharmacist Before Use If You Are (Ask a doctor or pharmacist before use if you are)
  • Presently taking a prescription drug for high blood pressure or depression.

Advanced Ingredient Data


Raw Label Data

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