Label: CVS HEMORRHOIDAL- glycerin phenylephrine hci pramoxine hci white 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 21, 2018

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  • ACTIVE INGREDIENT

    Active Ingredients                                  Purpose

    Glycerin 14.4%...................................... Protectant

    Phenylephrine HCI 0.25%........................ Vasoconstrictor

    Pramoxine HCI 1%..................................Local anesthetic

    White Petrolatum 15%.............................Protectant

  • PURPOSE

    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, irritaed anorectal surface to help make bowel movements less painful
  • WARNINGS

    Warnings

    For external use only

  • ASK DOCTOR

    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 DOCTOR/PHARMACIST

    Ask a doctor or pharmacist before use if you are presently taking a prescription drug for high blood pressure or depression

  • WHEN USING

    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
  • PREGNANCY OR BREAST FEEDING

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

  • KEEP OUT OF REACH OF CHILDREN

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

  • INDICATIONS & USAGE

    Directions

    • Adults: when practical, cleanse the affected area by patting or blottign with an appropriate cleansing wipe. Gently dry by patting or blotting with a tissue or a soft cloth before applying.
    • 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 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 dispensing cap partway into the anus.
    • Thoroughly cleanse dispensing cap after each use and replace cover.
    • Children under 12 years of age: ask a doctor
  • PURPOSE

    Other Information

    store at 20-25°C (68-77°F)

  • INACTIVE INGREDIENT

    Inactive ingredients

    aloe barbadensis leaf extract, butylated hydroxytoluene, cetosteraly alcohol, cetyl esters, cetyl palmitate, distilled water, glycerol monostearate, isopropyl myristate, lanolin, methylparaben, mineral oil, polysorbate 60, propylene glycol, propylparaben, sodium citrate hydrate, stearic acid, tocopherol acetate

  • DOSAGE & ADMINISTRATION

    DISTRIBUTED BY:

    CVS PHARMACY, INC.

    ONE CVS DRIVE

    WOONSOCKET, RI 02895 USA

  • PRINCIPAL DISPLAY PANEL

    48175

  • INGREDIENTS AND APPEARANCE
    CVS HEMORRHOIDAL 
    glycerin phenylephrine hci pramoxine hci white petrolatum cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59779-752
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN14.4 g  in 100 g
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE0.25 g  in 100 g
    PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056) PRAMOXINE HYDROCHLORIDE1 g  in 100 g
    PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM15 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    CETYL ESTERS WAX (UNII: D072FFP9GU)  
    CETYL PALMITATE (UNII: 5ZA2S6B08X)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    LANOLIN (UNII: 7EV65EAW6H)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59779-752-281 in 1 BOX09/12/2016
    11 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34601/17/2014
    Labeler - CVS Pharmacy, Inc. (062312574)
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