Label: ER HEMORRHOID- phenylephrine hcl cream

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

Drug Label Information

Updated February 2, 2024

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

  • Active Ingredients

    Mineral Oil                   14%
    Petrolatum                   74.9% 
    Phenylephrine HCI        0.25% 

  • Purpose

    Protectant
    Protectant
    Vasoconstrictor

  • 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

    For external use only.

  • ASK DOCTOR

    Ask a doctor before use if you have

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

    Ask a doctor or pharmacist before useif you are presently taking a prescription drug for high blood pressure or depression

  • WHEN USING

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

  • STOP USE

    Stop use and ask a doctor if

    • 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 healthcare professional before use

  • Keep out of reach of children

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

  • 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, puncture foil seal secured on tube
    • 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

  • Other Information

    • store at 20°-25°C (68°-77°F)
    • do not use if tube seal under cap is broken
  • Inactive Ingredients

    beeswax, ceteareth-20, cetostearyl alcohol, glycerin

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    ER HEMORRHOID 
    phenylephrine hcl cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72976-018
    Route of AdministrationRECTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MINERAL OIL (UNII: T5L8T28FGP) (MINERAL OIL - UNII:T5L8T28FGP) MINERAL OIL0.14 g  in 1 g
    PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM0.749 g  in 1 g
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE0.0025 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72976-018-0157 g in 1 TUBE; Type 0: Not a Combination Product02/02/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01502/02/2024
    Labeler - EVER READY FIRST AID (147372960)
    Registrant - Nantong Health & Beyond Hygienic Products Inc. (421280161)
    Establishment
    NameAddressID/FEIBusiness Operations
    Nantong Health & Beyond Hygienic Products Inc.421280161manufacture(72976-018)