TRONOLANE (PRAMOXINE HCL) CREAM [NEW GENESIS/MONTICELLO DRUG LLC]

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TRONOLANE (PRAMOXINE HCL) CREAM [NEW GENESIS/MONTICELLO DRUG LLC]
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NDC 11868-390-28, 11868-390-48, 11868-390-58, 11868-390-59
Set ID 0d5ba4f1-1178-490d-8524-143d0aa2f0ef
Category HUMAN OTC DRUG LABEL
Packager New Genesis/Monticello Drug LLC
Generic Name
Product Class
Product Number
Application Number PART347
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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredientsPurposes
    Pramoxine hydrochloride 1%Local anesthetic
    Zinc oxide 5%Astringent   
  • Uses

    • temporarily relieves pain, itching, burning and soreness associated with hemorrhoids.
  • Warnings

    For external use only. Certain persons can develop allergic reactions to ingredients in this product. If symptom being treated does not subside or if redness, irritation, swelling, pain or other symptoms develop or increase, discontinue use and consult a doctor.

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

    When using this product, do not exceed the recommended daily dose, unless directed by a doctor. Do not put this product in 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

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

  • Directions

    • Adults and children 12 years of age and older: Apply externally to the affected area up to 5 times daily.
    • When practical, cleanse the affected area with mild soap and warm water and rinse thoroughly or cleanse by patting or blotting with an appropriate cleansing pad.
    • Gently dry by patting or blotting with toilet tissue before application of this product.
    • To use applicator: Remove cap from tube and attach applicator. Gently squeeze tube to apply: do not insert applicator into rectum. Thoroughly cleanse applicator after use.
    • Children under 12 years of age: consult a doctor.
  • Other information

    • For your protection, do not use if glue end carton or seal under cap is broken.
  • Inactive ingredients

    beeswax, cetyl alcohol, cetyl esthers wax, glycerin, methylparaben, propylparaben, sodium lauryl sulfate, USP water

  • SPL UNCLASSIFIED SECTION

    Distributed by: New Genesis / Monticello Drug LLC
    Jacksonville, FL 32207

  • PRINCIPAL DISPLAY PANEL - 28 g Tube Carton

    NDC 11868-390-48

    Tronolane®
    Anesthetic Cream for Hemorrhoids

    DUAL-ACTION
    FORMULA

    Rapid Relief
    of Pain & Itching

    Odor-free • Non-greasy • Non-staining

    1 OZ (28 g)

    PRINCIPAL DISPLAY PANEL - 28 g Tube Carton
  • INGREDIENTS AND APPEARANCE
    TRONOLANE 
    pramoxine hcl cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11868-390
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056) PRAMOXINE HYDROCHLORIDE10 mg  in 1 g
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION50 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    CETYL ESTERS WAX (UNII: D072FFP9GU)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11868-390-481 in 1 CARTON12/04/2011
    1NDC:11868-390-2828 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:11868-390-591 in 1 CARTON03/04/2015
    2NDC:11868-390-5857 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34712/04/2011
    Labeler - New Genesis/Monticello Drug LLC (079396165)
    Registrant - ULTRAtab Laboratories, Inc. (151051757)
    Establishment
    NameAddressID/FEIBusiness Operations
    ULTRAtab Laboratories, Inc.151051757manufacture(11868-390)
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