Label: HEMORRHOIDAL PAIN RELIEF WITH ALOE AND VITAMINE cream

  • NDC Code(s): 13709-324-01
  • Packager: NeilMed pharmaceuticals Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 11, 2023

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

  • Drug Facts - Active Ingredients

    Glycerin 14.4%
    Phenylephrine Hydrochloride 0.25%
    Pramoxine Hydrochloride 1%
    White petrolatum 15%

  • Purpose


    Glycerin 14.4% ..................................................................... Protectant
    Phenylephrine Hydrochloride 0.25% ...............................Vasoconstrictor
    Pramoxine Hydrochloride 1% ...................................... Local Anesthetic
    White petrolatum 15% .......................................................... 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 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 in the rectum by using fingers or any mechanical device or applicator

  • Stop use and ask doctor if:

    􀁑􀀃Bleeding occurs 􀁑􀀃Condition worsens or does not improve within 7 days 􀁑􀀃An allergic reaction occurs 􀁑􀀃The symptom being treated does not subside or if redness, irritation, swelling, pain or other symptoms develop or increase.

  • If pregnant or breast-feeding

    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 (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 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. Lubricate dispensing 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.

  • Inactive ingredients:

    aloe barbadensis leaf extract, butylated hydroxytoluene, cetostearyl alcohol, cetyl esters, cetyl palmitate, glyceryl monostearate, isopropyl myristate, lanolin, methylparaben, mineral oil, polysorbate 60, propylene glycol, propylparaben, purified water, sodium citrate, stearic acid, tocopherol acetate

  • Questions?

    Questions? 1 (877) 477-8633

  • TAMPER EVIDENT:

    TAMPER EVIDENT: DO NOT USE IF SEAL ON TUBE IS PUNCTURED OR MISSING

  • Important

    Important: Please do not discard this printed box and any enclosed printed material. The inside final product may not have all the details you require for the ongoing use of the product.

  • Use

    swollen hemorrhoidal tissue, to get quick temporary relief from pain, burning, itching& irritation

  • Package label _Outer carton

    Pain Relief Cream with Aloe

  • INGREDIENTS AND APPEARANCE
    HEMORRHOIDAL PAIN RELIEF WITH ALOE AND VITAMINE 
    hemorrhoidal pain relief with aloe and vitamine cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13709-324
    Route of AdministrationRECTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE25 mg  in 1 g
    PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM150 mg  in 1 g
    PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056) PRAMOXINE HYDROCHLORIDE10 mg  in 1 g
    GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN144 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    WATER (UNII: 059QF0KO0R)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    CETYL PALMITATE (UNII: 5ZA2S6B08X)  
    LANOLIN (UNII: 7EV65EAW6H)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    ALOE (UNII: V5VD430YW9)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    CETYL ESTERS WAX (UNII: D072FFP9GU)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13709-324-011 in 1 CARTON10/11/2023
    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 DrugM01510/11/2023
    Labeler - NeilMed pharmaceuticals Inc. (799295915)
    Establishment
    NameAddressID/FEIBusiness Operations
    NeilMed Pharmaceuticals Inc.799295915manufacture(13709-324)