Label: FAMILY WELLNESS HEMORRHOIDAL- mineral oil, petrolatum, and phenylephrine hcl ointment

  • NDC Code(s): 55319-381-56
  • Packager: Family Dollar Services, Inc
  • 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 September 25, 2023

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    Drug Facts

    Active ingredients Purposes

    Mineral oil 14.0%.....................................................................Skin protectant

    Petrolatum 74.9%....................................................................Skin protectant

    Phenylephrine HCI 0.25%........................................................Vasoconstrictor

  • PURPOSE

    Uses

    • helps relieve 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

    Warnings

    For external and/or intrarectal use only

  • DO NOT USE

    Do not use this product if you have

    • heart disease
    • high blood pressure
    • thyroid disease
    • difficulty in urination due to enlargement of the prostate gland
    • diabetes
  • ASK DOCTOR

    Ask a doctor of pharmacist before use if you are presently taking a prescription drug for high blood pressure or depression.

  • WHEN USING

    When using this product do not exceed the recommended daily dosage unless directed by a doctor

  • STOP USE

    Stop use and ask a doctor if

    • rectal bleeding occurs
    • condition worsens or does not improve within 7 days
    • introduction of applicator into the rectum causes additional pain
  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeding, ask a health professional before use.

  • KEEP OUT OF REACH OF CHILDREN

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

  • INDICATIONS & USAGE

    Directions

    • 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, peel back foil seal
    • apply 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 applicator, attach applicator to tube, lubricate applicator well and gently insert applicator into rectum. Thoroughly clean applicator after each use and replace cover. Also apply ointment to external area.
    • regular use provides continue therapy for relief of symptoms
    • children under 12 years of age: ask a doctor
  • STORAGE AND HANDLING

    Other information store at room temperature 20-25°C (68-77°F)

  • INACTIVE INGREDIENT

    Inactive ingredients alcohol, alpha tocopherol acetate, glycerin, lanolin, methylparaben, polysorbate 80, propylparaben, purified water, stearyl alcohol, thyme oil, white wax

  • DOSAGE & ADMINISTRATION

    Distributed by: Midwood Brands, LLC

    500 Volvo Pkwy, Chesapeake, VA 23320 USA
    Made in China

  • PRINCIPAL DISPLAY PANEL

    91319

  • INGREDIENTS AND APPEARANCE
    FAMILY WELLNESS HEMORRHOIDAL 
    mineral oil, petrolatum, and phenylephrine hcl ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55319-381
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM749 mg  in 1 g
    MINERAL OIL (UNII: T5L8T28FGP) (MINERAL OIL - UNII:T5L8T28FGP) MINERAL OIL140 mg  in 1 g
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE2.5 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    WATER (UNII: 059QF0KO0R)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    THYME OIL (UNII: 2UK410MY6B)  
    WHITE WAX (UNII: 7G1J5DA97F)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    ALCOHOL (UNII: 3K9958V90M)  
    LANOLIN (UNII: 7EV65EAW6H)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55319-381-561 in 1 CARTON09/18/2023
    157 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalM01509/18/2023
    Labeler - Family Dollar Services, Inc (024472631)