Label: PREFERRED PLUS HEMORRHOID- glycerin, petrolatum, phenylephrine hydrochloride, pramoxine hydrochloride 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 January 24, 2018

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredients

    Glycerin 14.4%

    Petrolatum 15%

    Phenylephrine HCl 0.25%

    Pramoxine HCl1 %

  • Purposes

    Protectant

    Protectant

    Vasoconstrictor

    Local anesthetic

  • Uses

    • helps relieve the local itching and discomfort associated with hemorrhoids
    • temporarily shrinks hemorrhoidal tissue
    • temporarily relieves burning
    • aids in protecting irritated anorectal areas
  • Warnings

    For external use only

    Ask a doctor before use if you have

    • heart disease
    • high blood pressure
    • diabetes
    • thyroid disease
    • 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 this product into the rectum by using fingers or any mechanical device or applicator

    Stop use and ask a doctor if

    • bleeding occur
    • condition gets worse or does not Improve within 7 days

    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 and gently dry the affected area by patting or blotting with an appropriate cleansing tissue or soft cloth before applying gel
    • when first opening the tube, puncture foil seal with top end of cap
    • apply externally to the affected area up to 4 times daily, especially at night, in the morning or after each bowel movement
    • Children under 12 years of age: ask a doctor
  • Other information

    • store at 20°-25°C (68°-77°F)
    • for lot number and expiration date, see crimp of tube or see box
  • Inactive ingredients

    • cetearyl alcohol, cetyl alcohol, monosterate, mineral oil, peg 40 castor oil, propylene glycol, purified water, stearyl alcohol, tocopheryl acetate (Vitamin E)
  • Principal Display Panel - 1 oz Carton Label

    TAMPER-EVIDENT: Do not use if printed "safety sealed" overwrap is broken or missing.

    NDC 61715-092-01

    Preferred Plus Pharmacy®

    HEMORRHOIDAL

    CREAM Maximum Strength Pain Relief

    *Compare to the active ingredients in PREPARATION H® Cooling Gel

    Smooth Cream Formula

    • Rapid Soothing Pain Relief from Painful Burning, Itching and Discomfort
    • Shrinks Swollen Hemorrhoidal Tissue
    • Protects Irritated Tissue
    • Relieves External Discomfort

    SATISFACTION GUARANTEED

    Preferred Plus Pharmacy®

    NET WT 1 OZ (28 g)

    Principal Display Panel - 1 oz Carton Label
  • INGREDIENTS AND APPEARANCE
    PREFERRED PLUS HEMORRHOID 
    glycerin, petrolatum, phenylephrine hydrochloride, pramoxine hydrochloride cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61715-092
    Route of AdministrationRECTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Glycerin (UNII: PDC6A3C0OX) (Glycerin - UNII:PDC6A3C0OX) Glycerin144 mg  in 1 L
    Petrolatum (UNII: 4T6H12BN9U) (Petrolatum - UNII:4T6H12BN9U) Petrolatum150 mg  in 1 L
    Phenylephrine Hydrochloride (UNII: 04JA59TNSJ) (Phenylephrine - UNII:1WS297W6MV) Phenylephrine Hydrochloride2.5 mg  in 1 L
    Pramoxine Hydrochloride (UNII: 88AYB867L5) (Pramoxine - UNII:068X84E056) Pramoxine Hydrochloride10 mg  in 1 L
    Inactive Ingredients
    Ingredient NameStrength
    Aloe Vera Leaf (UNII: ZY81Z83H0X)  
    Cetostearyl Alcohol (UNII: 2DMT128M1S)  
    Cetyl Alcohol (UNII: 936JST6JCN)  
    Glyceryl Monostearate (UNII: 230OU9XXE4)  
    Mineral Oil (UNII: T5L8T28FGP)  
    Peg-40 Castor Oil (UNII: 4ERD2076EF)  
    Water (UNII: 059QF0KO0R)  
    Propylene Glycol (UNII: 6DC9Q167V3)  
    Stearyl Alcohol (UNII: 2KR89I4H1Y)  
    .ALPHA.-Tocopherol Acetate (UNII: 9E8X80D2L0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61715-092-011 in 1 CARTON03/28/2014
    10.028 L in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34603/28/2014
    Labeler - Kinray, Inc. (012574513)
    Establishment
    NameAddressID/FEIBusiness Operations
    PJ Noyes Company018927392MANUFACTURE(61715-092)
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