FAMILY CARE HEMORRHOIDAL (MINERAL OIL) OINTMENT [UNITED EXCHANGE CORP]

FAMILY CARE HEMORRHOIDAL (MINERAL OIL) OINTMENT [UNITED EXCHANGE CORP]
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NDC 65923-003-20
Set ID 04375257-f4f3-48c3-a338-de43298b95eb
Category HUMAN OTC DRUG LABEL
Packager United Exchange Corp
Generic Name
Product Class alpha-1 Adrenergic Agonist
Product Number
Application Number PART346
  • 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)

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