Label: FAMILY CARE HEMORRHOIDAL- mineral oil ointment

  • Category: HUMAN OTC DRUG LABEL

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 March 31, 2022

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  • ACTIVE INGREDIENT

    Active ingredients                                                        Purpose

    Mineral oil 14%.........................................................Protectant

    Petrolatum 74.9%.....................................................Protectant

    Phenylephrine HCl 0.25%...................................Vasoconstrictor

  • PURPOSE

    Uses

    • helps relieve the local itching and discomfort associated with hemorrhoids
    • temporarily shrinks hemorrhoidal tissue and relieve 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 use only / or intrarectal use only

  • ASK DOCTOR

    Ask a doctor before use if you have

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

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

  • WHEN USING

    When using this product do not use more than the recommended daily dosage unless directed by a doctor

  • STOP USE

    Stop use and ask a doctor if

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

    If pregnant or breast-feeding, ask a physician 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.

  • 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 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
    • intrarectal use: remove cover from applicator, attach applicator to tube, lubricate applicator well and 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

    Other information

    • store at 20° C to 25°C (68° to 77°F)
  • INACTIVE INGREDIENT

    Inactive ingredients

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

  • DOSAGE & ADMINISTRATION

    Distributed by:

    United Exchange Corp

    Cypress, CA 90630 USA

    Made in China

  • PRINCIPAL DISPLAY PANEL

    515

  • INGREDIENTS AND APPEARANCE
    FAMILY CARE HEMORRHOIDAL 
    mineral oil ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65923-003
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MINERAL OIL (UNII: T5L8T28FGP) (MINERAL OIL - UNII:T5L8T28FGP) MINERAL OIL140 mg  in 100 g
    PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM749 mg  in 100 g
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE2.5 mg  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    LANOLIN (UNII: 7EV65EAW6H)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    THYME OIL (UNII: 2UK410MY6B)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    WATER (UNII: 059QF0KO0R)  
    WHITE WAX (UNII: 7G1J5DA97F)  
    ALCOHOL (UNII: 3K9958V90M)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65923-003-201 in 1 CARTON11/24/2014
    120 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34611/24/2014
    Labeler - United Exchange Corp (840130579)