Label: MEGABABE BUTT STUFF HEMORRHOIDAL- cocoa butter, glycerin, lidocaine, petrolatum, phenylephrine hydrochloride ointment

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated June 12, 2024

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  • 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.

  • Package Labeling:

    Outer LabelInner Label

  • INGREDIENTS AND APPEARANCE
    MEGABABE BUTT STUFF HEMORRHOIDAL 
    cocoa butter, glycerin, lidocaine, petrolatum, phenylephrine hydrochloride ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:84000-502
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    COCOA BUTTER (UNII: 512OYT1CRR) (COCOA BUTTER - UNII:512OYT1CRR) COCOA BUTTER125 mg  in 1 g
    GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN250 mg  in 1 g
    LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE50 mg  in 1 g
    PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM125 mg  in 1 g
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE2.5 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    WATER (UNII: 059QF0KO0R)  
    ASCORBIC ACID (UNII: PQ6CK8PD0R)  
    BEHENTRIMONIUM METHOSULFATE (UNII: 5SHP745C61)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    OATMEAL (UNII: 8PI54V663Y)  
    DECYL GLUCOSIDE (UNII: Z17H97EA6Y)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    GLYCERYL LAURATE (UNII: Y98611C087)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)  
    HAMAMELIS VIRGINIANA TOP WATER (UNII: NT00Y05A2V)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    AVOCADO OIL (UNII: 6VNO72PFC1)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:84000-502-001 in 1 BOX06/06/2024
    135 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01506/06/2024
    Labeler - MEGABABE, LLC (081154311)
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