Label: ATOPALM HEMORRHOIDAL- mineral oil, petrolatum, phenylephrine hydrochloride ointment

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated July 18, 2012

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  • Active Ingredients

    Mineral Oil 14%

    Petrolatum 71.9%

    Phenylephrine HCl 0.25%

    Purpose

    Protectant
    Protectant
    Vascocontrictor

  • Uses

    ■ for temporary relief of the local itching and discomfort associated with hemorrhoids

    ■ temporarily shrinks hemorrhoidal tissue and relieves burning

    ■ temporarily provides a coating for relief of anorectal discomforts

    ■ temporarily protects the inflamed, irritated anorectal surface to help make bowel movements less painful.

  • Warnings

    For external and/or intrarectal use only.

    Ask a doctor before using if you have

    ■ heart disease ■ high blood pressure ■ thyroid disease ■ diabetes ■ trouble urinating due to an enlarged prostate gland

    Ask a doctor of pharmacist before use if you are

    ■ presently taking a prescription drug for high blood pressure or depression.

    When using this product

    ■ do not exceed the recommended daily dosage unless directed by a doctor

    Stop use and ask a doctor if

    ■ bleeding occurs
    ■ condition worsens or does not improve within 7 days
    ■ introduction of the applicator into the rectum causes additional pain.

    If pregnant or breast feeding,

    ask a health professional before use.

    Keep out of reach of children.

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

  • Directions

    Do not use if foil seal under cap is broken or missing.

    ■ adults: when practical, cleanse the affected area by patting or blotting with an appropriate cleansing wipe. Gently dry by patting or blotting with a tissue or a soft cloth before applying ointment
    ■ when first opening the tube, puncture foil seal with top end of cap
    ■ apply externally to the affected area up to 4 times daily, especially at night, in the morning or after each bowel movement
    ■ for intrarectal use, remove cover from the applicator, attach applicator to tube, lubricate applicator well, then gently insert applicator into the rectum
    ■ thoroughly cleanse applicator after each use and replace cover
    ■ also apply ointment to external area
    ■ regular use provides continual therapy for relief of
    symptoms
    ■ children under 12 years of age, ask a doctor.
  • STORAGE AND HANDLING

    store at 20° – 25°C (68° – 77°F)

  • Inactive Ingredients

    COD LIVER OIL, GLYCERIN, LANOLIN, BEES WAX, SQUALANE, CHOLESTEROL, MYRISTOYL/PALMITOYL OXOSTEARAMIDE/ARACHAMIDE MEA, STEARIC ACID, BUTYLATED HYDROXYTOLUENE, METHYLPARABEN, PARAFFIN, PROPYLPARABEN, PURIFIED WATER, SODIUM BENZOATE, THYMUS VULGARIS (THYME) FLOWER/LEAF OIL, TOCOPHERYL ACETATE.

  • Questions or information call toll free

    1-855- ATOPALM

  • ATOPALM Hemorrhoidal Ointment 2oz (51141-0230-2)

    Outer Package
    OuterPackage1

    OuterPackage2


    Inner Package
    InnerPackage

  • INGREDIENTS AND APPEARANCE
    ATOPALM HEMORRHOIDAL 
    mineral oil, petrolatum, phenylephrine hydrochloride ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51141-0230
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MINERAL OIL (UNII: T5L8T28FGP) (MINERAL OIL - UNII:T5L8T28FGP) MINERAL OIL14 g  in 100 g
    PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM71.9 g  in 100 g
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE0.25 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    COD LIVER OIL (UNII: BBL281NWFG)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    LANOLIN (UNII: 7EV65EAW6H)  
    SQUALANE (UNII: GW89575KF9)  
    CHOLESTEROL (UNII: 97C5T2UQ7J)  
    MYRISTOYL/PALMITOYL OXOSTEARAMIDE/ARACHAMIDE MEA (UNII: 1211AIM8G7)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    PARAFFIN (UNII: I9O0E3H2ZE)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    THYME OIL (UNII: 2UK410MY6B)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51141-0230-21 in 1 CARTON
    156 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34607/18/2012
    Labeler - NeoPharm USA (965502912)
    Establishment
    NameAddressID/FEIBusiness Operations
    NeoPharm Co., Ltd.631101883manufacture(51141-0230)
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