Label: HEMORRHOIDAL CREAM cream

  • NDC Code(s): 0363-0641-09, 0363-0641-10
  • Packager: Walgreens
  • 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 December 22, 2020

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • Active Ingredients

    Glycerin 14.4%

    Phenylephrine HCL  0.25%

    Pramoxine HCl  1%

    White petrolatum  15%

  • Purpose

    Protectant

    Vasoconstrictor

    Local anasthetic

    Protectant

  • 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

    -difficulty in urination due to 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

    -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 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.  Lubrcate 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.

  • Directions

    Apply externally or in the lower portion of the anal canal only. Apply 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. Lubrcate dispensing cap well, then gently insert dispensing cap partway into the anus.

  • Other information

    store at 20-25oC (68-77oF)

  • Inactive ingredients

    Aloe barbadensis leaf extract, butylated hydroxytoluene, cetyl esters, cetyl palmitate, glyceryl monostearate, isopropyl myristate, lanolin, methylparaben, mineral oil, polysorbate 60, propylene glycol, propylparaben, sodium citrate, stearic acid, stearyl alcohol, vitamin E, water

  • Carton label

    carton label

  • Tube label

    Tube label

  • INGREDIENTS AND APPEARANCE
    HEMORRHOIDAL CREAM 
    hemorrhoidal cream cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-0641
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM15 g  in 100 g
    GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN14.4 g  in 100 g
    PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056) PRAMOXINE HYDROCHLORIDE1 g  in 100 g
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE0.25 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R) 37.45 g  in 100 g
    POLYSORBATE 60 (UNII: CAL22UVI4M) 10 g  in 100 g
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3) 4 g  in 100 g
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y) 3.3 g  in 100 g
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) 3.2 g  in 100 g
    MINERAL OIL (UNII: T5L8T28FGP) 2 g  in 100 g
    CETYL PALMITATE (UNII: 5ZA2S6B08X) 1 g  in 100 g
    ALOE (UNII: V5VD430YW9) 1 g  in 100 g
    SODIUM CITRATE (UNII: 1Q73Q2JULR) 1 g  in 100 g
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) 0.8 g  in 100 g
    STEARIC ACID (UNII: 4ELV7Z65AP) 2 g  in 100 g
    LANOLIN (UNII: 7EV65EAW6H) 0.5 g  in 100 g
    METHYLPARABEN (UNII: A2I8C7HI9T) 0.20 g  in 100 g
    PROPYLPARABEN (UNII: Z8IX2SC1OH) 0.10 g  in 100 g
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0363-0641-091 in 1 PACKAGE03/25/2018
    1NDC:0363-0641-1025.5 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34803/25/2018
    Labeler - Walgreens (008965063)
    Establishment
    NameAddressID/FEIBusiness Operations
    Unipack009248480manufacture(0363-0641)