Label: CVS HEALTH HEMORRHOIDAL CREAM- glycerin, phenylephrine hcl, pramoxine hcl, white petrolatum cream

  • NDC Code(s): 69571-010-28
  • Packager: FRONT PHARMACEUTICAL PLC
  • 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 December 18, 2019

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    Active ingredients

    Glycerin 14.4%

    Phenylephrine HCl 0.25%

    Pramoxine HCl 1%

    White petrolatum 15%

  • PURPOSE

    Purpose

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

    Phenylephrine HCl 0.25% .............Vasoconstrictor

    Pramoxine HCl 1%........................Local anesthetic

    White petrolatum 15%..................Protectant

  • INDICATIONS & USAGE

    Uses  •for temporary relief of pain, soreness and burning •helps relieve

    the local itching and discomfort associated ith hemorrhoids

    •temporarily provides a coating for f of anorectal discomforts

    •temporarily protects the inflamed irritated anorectal surface to help make

    bowel movements less painful  •temporarily shrinks hemorrhoidal tissue

  • WARNINGS

    Warnings

    For external use only.

    When using this product •do not put this product into the rectum by

    using fingers or any mechanical device or applicator •do not exceed

    recommended daily dosage unless directed by a doctor

    Ask a doctor before use ifyou 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 depsression

    Stop use and ask a doctor if

    •bleeding occurs •condition worsens or does not improve within 7 days

    •if the symptoms being treated do not subside or if redness, irritation,

    swelling, pain or other symptoms develop or increase. Some people can

    develop allergic reactions to ingredients in this product.

    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 Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    Directions Adults:

    •when practical, cleanse the affected area with mild soap and water and rinse thoroughly.

    Gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product.

    •apply externally to the affected area up to 4 times daily, especially at night or in the

    morning or after each bowel movement.

    Children under 12 years of age: consult a doctor.

  • STORAGE AND HANDLING

    Other information store at room temperature 68° - 77° F (20° -  25° C)

  • INACTIVE INGREDIENT

    Inactive ingredients aloe barbadensis leaf extract, carboxymethyllcellulose

    sodium, cetyl alcohol, glyceryl monostearate, methylparaben, paraffin, propylene

    glycol, propylparaben, stearic acid, tween 80, water, xanthan gum

  • QUESTIONS

    Questions? 1-800-639-3803 Weekdays 9 AM to 4 PM EST

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    CVS HEALTH   HEMORRHOIDAL CREAM
    glycerin, phenylephrine hcl, pramoxine hcl, white petrolatum cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69571-010
    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) PHENYLEPHRINE0.25 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)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PARAFFIN (UNII: I9O0E3H2ZE)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    WATER (UNII: 059QF0KO0R)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69571-010-281 in 1 BOX02/12/2018
    128 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34602/12/2018
    Labeler - FRONT PHARMACEUTICAL PLC (530897792)
    Establishment
    NameAddressID/FEIBusiness Operations
    FRONT PHARMACEUTICAL PLC530897792manufacture(69571-010)