Label: ANESTHETIC HEMORRHOIDAL WITH ALOE- pramoxine hydrochloride, zinc oxide ointment

  • NDC Code(s): 29500-2438-1
  • Packager: Personal Care Products, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 July 23, 2020

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

  • Drug Facts Active Ingredient

    Pramoxine HCL 1%

    Zinc oxide 12.5%

  • Purpose

    Local anesthetic
    Protectant

  • Keep out of reach of children

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • Uses

    temporarily shrinks hemorrhoidal tissue
    temporarily relieves itching, burning and discomfort associated with hemorrhoids

  • 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 use this product with an applicator, if the applicator into the rectum causes additional pain. Consult a doctor promptly.

    Stop use and ask a doctor if - you experience bleeding, condition worsens or does not improve within 7 days, these may be signs of a serious condition.

    If pregnant or breast-feeding, ask a health professional before use.

  • Directions

    Direction for adults

    when practical, cleanse the affected area by patting or blotting with an appropriate cleansing tissue. Gently dry by patting or blotting with toilet tissue or soft cloth before application of this ointment, apply to the affected area up to 4 times daily, especially at night, in the morning or after each bowel movement

    Children under 12 years or age, ask a doctor.

  • Other information

    store between 59° and 86° F (15° and 30° C), close cap tightly after use, do not use if seal on tube is punctured  or missing

  • Inactive ingredients

    balsam peru, benzyl benzoate, calcium phohsphate, cocoa butter, glyceryl monostearate, glyceryl monoleate, kaolin, mineral oil, Aloe vera extract

  • Product Label

    DRUGSTORE - Rx

    SMART WELLNESS

    Anesthetic Hemorrhoidal Ointment With Aloe

    Quick and soothing, pain relief from burning, itching and discomfort

    Shrinks swollen hemorrhoidal tissue

    NET WT. 1.5 OZ. (42 g)

    DRUGSTORE-Rx

    SMART WELLNESS delivers outstanding quality in healthcare products, at truly amazing prices. We employ the highest standard when searching the world to bring the best value to your doorstep. Use our products confidently, knowing that attention and care has gone into every item  That's smart wellness!

    Distributed by: PERSONAL CARE PRODUCTS, LLC

    Troy, Michigan 484084  U.S.A.       Code No.MH/DRUGS/KD-313    Made in India


    PC Hemorrhodial1 Label

    PC Hemorrhodial4 Label


  • INGREDIENTS AND APPEARANCE
    ANESTHETIC HEMORRHOIDAL  WITH ALOE
    pramoxine hydrochloride, zinc oxide ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:29500-2438
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056) PRAMOXINE HYDROCHLORIDE420 mg  in 42 g
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE5.25 g  in 42 g
    Inactive Ingredients
    Ingredient NameStrength
    BALSAM PERU (UNII: 8P5F881OCY)  
    BENZYL BENZOATE (UNII: N863NB338G)  
    CALCIUM PHOSPHATE (UNII: 97Z1WI3NDX)  
    COCOA BUTTER (UNII: 512OYT1CRR)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    KAOLIN (UNII: 24H4NWX5CO)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    GLYCERYL OLEATE (UNII: 4PC054V79P)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:29500-2438-142 g in 1 TUBE; Type 0: Not a Combination Product06/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34707/10/2013
    Labeler - Personal Care Products, Inc. (966155082)
    Registrant - Personal Care Products, Inc. (966155082)
    Establishment
    NameAddressID/FEIBusiness Operations
    Anicare Pharmaceuticals Pvt. Ltd.916837425manufacture(29500-2438)