Label: HEMORRHOIDAL- petrolatum, mineral oil, phenylephrine hcl ointment

  • NDC Code(s): 63941-202-02
  • Packager: Valu Merchandisers, Co.
  • 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 February 8, 2023

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

  • 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 and/or intrarectal use only

    Ask a doctor before use if you have

    • heart disease
    • high blood pressure
    • thyroid disease
    • diabetes
    • trouble urinating due to an enlargement of the prostate gland

    Ask a doctor or 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 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 or contact a Poison Control Center right away.

  • 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, puncture foil seal with top end of cap
    • 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 form applicator and attach 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
  • Other information

    Other information

    Store at 20 o to 25 oC (68 o to 77 oF)

  • Inactive ingredients

    beeswax, benzoic acid, cetyl alcohol, blyerol, methylparaben, polyoxyethylene lauryl ether, propylparaben, stearyl alcohol

  • Active ingredients

    Mineral oil 14%

    Petrolatum 74.9%

    Phenylephrine HCL 0.25%

  • Purpose

    Protectant

    Protectant

    Vasoconstrictor


  • Questions or comments?

    Call toll free: 1-800-883-0085

  • Package label

    Best Choice Hemorrhoidal Ointment

    carton

  • INGREDIENTS AND APPEARANCE
    HEMORRHOIDAL 
    petrolatum, mineral oil, phenylephrine hcl ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63941-202
    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) PETROLATUM74.9 g  in 100 g
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE0.25 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    GLYCEROL FORMAL (UNII: 3L7GR2604E)  
    .ALPHA.-SUCCINIMIDYLOXY CARBONYL-.OMEGA.-METHOXY, POLYOXYETHYLENE MW 5000 (UNII: C9D1AW3UTV)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    PEG-8 BEESWAX (UNII: 3C1QUF1TIR)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63941-202-021 in 1 CARTON02/06/2012
    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 finalpart34602/06/2012
    Labeler - Valu Merchandisers, Co. (868703513)