CVS HEMORRHOIDAL (PRAMOXINE HYDROCHLORIDE, GLYCERIN, PHENYLEPHRINE HYDROCHLORIDE AND PETROLATUM) CREAM [CVS PHARMACY]

CVS HEMORRHOIDAL (PRAMOXINE HYDROCHLORIDE, GLYCERIN, PHENYLEPHRINE HYDROCHLORIDE AND PETROLATUM) CREAM [CVS PHARMACY]
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NDC 59779-403-60, 59779-403-61
Set ID 37b1e849-3079-4f8e-b712-9520a1e0dd89
Category HUMAN OTC DRUG LABEL
Packager CVS Pharmacy
Generic Name
Product Class alpha-1 Adrenergic Agonist
Product Number
Application Number PART346
  • ACTIVE INGREDIENT

    Active ingredients                                 Purpose

    Glycerin 14.4%.................................................Protectant
    Petrolatum 15.0%.............................................Protectant
    Phenylephrine Hydrochloride.............................Vasoconstrictor
    Pramoxine Hydrochloride..................................Local anesthetic


  • PURPOSE

    Active ingredients                                 Purpose

    Glycerin 14.4%.................................................Protectant
    Petrolatum 15.0%.............................................Protectant
    Phenylephrine Hydrochloride.............................Vasoconstrictor
    Pramoxine Hydrochloride..................................Local anesthetic

    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
  • 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.
  • INDICATIONS & USAGE

    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
     

    Other information
    - store at 20 degrees - 25 degrees C (68 degrees - 77 degrees F)

  • WARNINGS

    Warnings

    For external use only.

    Ask a doctor before use if you have

    - heart disease - high blood pressure - thyroid disease - diabetes
    - 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 into 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 the reach of children. If swallowed, get medical help or contact a Poison Control Center right away
  • DOSAGE & ADMINISTRATION


    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 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 externally 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 cap well, then gently
    insert 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 INGREDIENT

    Inactive Ingredients aloe barbadensis leaf juice, butylated hydroxyanisole,
    cellulose gum, cetyl alcohol, citric acid, disodium EDTA, glyceryl stearate SE,
    laureth-23, methylparaben, mineral oil, penthenol, propylene glycol, propyl gallate,
    propylparaben, purified water, sodium benzoate, steareth-2, steareth-20,
    stearyl alcohol, tocopheryl acetate, xanthan gum


  • PRINCIPAL DISPLAY PANEL

    c


  • INGREDIENTS AND APPEARANCE
    CVS HEMORRHOIDAL 
    pramoxine hydrochloride, glycerin, phenylephrine hydrochloride and petrolatum cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59779-403
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056) PRAMOXINE HYDROCHLORIDE10 mg  in 1 g
    GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN144 mg  in 1 g
    PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM150 mg  in 1 g
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE2.5 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    LAURETH-23 (UNII: N72LMW566G)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    PROPYL GALLATE (UNII: 8D4SNN7V92)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    STEARETH-2 (UNII: V56DFE46J5)  
    STEARETH-20 (UNII: L0Q8IK9E08)  
    .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59779-403-601 in 1 CARTON
    128 g in 1 TUBE, WITH APPLICATOR
    2NDC:59779-403-611 in 1 CARTON
    251 g in 1 TUBE, WITH APPLICATOR
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34612/15/2010
    Labeler - CVS Pharmacy (062312574)
    Registrant - Pharma Pac, LLC (140807475)
    Establishment
    NameAddressID/FEIBusiness Operations
    Pharma Pac, LLC140807475manufacture

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