MegaBabe Butt Stuff Hemorrhoidal Ointment

Manufacturer
MEGABABE, LLC
Effective date
2024-06-12
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:13:31

Label at a glance#

ProductMegaBabe Butt Stuff Hemorrhoidal
Active ingredientCOCOA BUTTER, GLYCERIN, LIDOCAINE, PETROLATUM, PHENYLEPHRINE HYDROCHLORIDE
Label structure7 sections

Indications and 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.

Dosage and administration

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.

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Cocoa Butter 12.5%

Glycerin 25%

Lidocaine 5%

Petrolatum 12.5%

Phenylephrine HCL 0.25%

Purposes

OTC - PURPOSE SECTION

Protectant

Local Anesthetic

Vasoconstrictor

Uses:

INDICATIONS & USAGE SECTION

  • 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:

WARNINGS SECTION

For external use only.

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

Do not

OTC - DO NOT USE SECTION

  • 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

OTC - ASK DOCTOR/PHARMACIST SECTION

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

When using this product

OTC - WHEN USING SECTION

  • 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

OTC - STOP USE SECTION

  • 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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

If pregnant or breastfeeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Directions:

DOSAGE & ADMINISTRATION SECTION

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:

SPL UNCLASSIFIED SECTION

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

Inactive Ingredients:

INACTIVE INGREDIENT SECTION

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.

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Outer LabelOuter LabelInner LabelInner Label

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
GLYCERIN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
LIDOCAINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
PHENYLEPHRINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84000-502-00MegaBabe Butt Stuff Hemorrhoidal1 in 1 BOXOINTMENT11
84000-502-00MegaBabe Butt Stuff Hemorrhoidal35 g in 1 TUBEOINTMENT351

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84000-502MEGABABE BUTT STUFF HEMORRHOIDAL (COCOA BUTTER, GLYCERIN, LIDOCAINE, PETROLATUM, PHENYLEPHRINE HYDROCHLORIDE) OINTMENT [MEGABABE, LLC]1Current NDC, 2 package rows20240613_01c156ff-69f9-4d5e-a9ea-abbc52d4afff.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 34 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
84000-50284000-502-00

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 31 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MegaBabe Butt Stuff HemorrhoidalCOCOA BUTTER, GLYCERIN, LIDOCAINE, PETROLATUM, PHENYLEPHRINE HYDROCHLORIDEMEGABABE, LLC01c156ff-69f9-4d5e-a9ea-abbc52d4afff2024-06-12WarningsExact identifier
ndc (package): 84000-502-00
ndc (product): 84000-502
ndc11 (package): 84000050200
spl id: 1aad3a81-c4c1-d1d6-e063-6394a90a7cb8
spl set id: 01c156ff-69f9-4d5e-a9ea-abbc52d4afff

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.