Label: EQUALINE HEMORRHOIDAL- glycerin, phenylephrine hcl, pramoxine hcl, white petrolatum cream

  • 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 December 11, 2019

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

  • Active ingredients

    Glycerin 14.4%

    Phenylephrine HCl 0.25%

    Pramoxine HCl 1%

    White petrolatum 15%

  • Purpose

    Protectant

    Vasoconstrictor

    Local anesthetic

  • Uses

    for temporary relief of pain, soreness and burning
    helps relieve the local itching and discomfort associated with hemorrhoids
    temporarily shrinks hemorrhoidal tissue
    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 a doctor before use if you have

    heart disease
    high blood pressure
    thyroid disease
    diabetes
    trouble urinating due to an enlarged 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
    do not put into the rectum by using fingers or any mechanical device or applicator

    Stop use and ask a doctor if

    bleeding occurs
    condition worsens or does not improve within 7 days
    an allergic reaction develops
    the symptom being treated does not subside or if redness, irritation, swelling, pain, or other symptoms develop or increase

    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 cream.
    when first opening the tube, puncture foil seal with top end of cap
    apply externally or in the lower portion of the anal canal only
    apply externally to the affected area up to 4 times daily, especially at night, in the morning or after each bowel movement
    for application in the lower anal canal: remove cover from dispensing cap. Attach dispensing cap to tube. Lubricate dispensing cap well, then gently insert dispensing cap partway into the anus.
    thoroughly cleanse dispensing cap after each use and replace cover
    children under 12 years of age: ask a doctor
  • Other information

    store at 20°-25°C (68°-77°F)
  • Inactive ingredients

    aloe barbadensis leaf extract, butylated hydroxyanisole, carboxymethylcellulose sodium, cetyl alcohol, citric acid, edetate disodium, glyceryl monostearate, laureth-23, methylparaben, mineral oil, panthenol, propyl gallate, propylparaben, purified water, sodium benzoate, steareth-2, steareth-20, stearyl alcohol, vitamin E, xanthan gum

  • Questions or comments?

    1-877-932-7948

  • Principal Display Panel

    compare to Preparation H® Cream active ingredients

    hemorrhoidal cream

    rapid soothing pain relief from painful burning, itching and discomfort

    shrinks swollen hemorrhoidal tissue – protects irritated tissue

    relieves external discomfort

    maximum strength pain relief – smooth cream formula with aloe

    NET WT 1.8 OZ (51g)

    Equaline Hemorrhoidal Cream Image
  • INGREDIENTS AND APPEARANCE
    EQUALINE HEMORRHOIDAL 
    glycerin, phenylephrine hcl, pramoxine hcl, white petrolatum cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41163-944
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN14.4 g  in 100 g
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE0.25 g  in 100 g
    PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056) PRAMOXINE HYDROCHLORIDE1 g  in 100 g
    PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM15 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U)  
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    LAURETH-23 (UNII: N72LMW566G)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    PROPYL GALLATE (UNII: 8D4SNN7V92)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    STEARETH-2 (UNII: V56DFE46J5)  
    STEARETH-20 (UNII: L0Q8IK9E08)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:41163-944-241 in 1 CARTON03/28/2008
    151 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34603/28/2008
    Labeler - Supervalu Inc (006961411)