Label: CVS HEMORRHOIDAL- pramoxine hydrochloride, glycerin, phenylephrine hydrochloride and petrolatum cream

  • Category: HUMAN OTC DRUG LABEL

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 December 15, 2010

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  • 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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