Label: REVIVOL HEMORRHOID AND FISSURE- glycerin 14.4%, lidocaine 5%, petrolatum 15%, phenylephrine hcl 0.25% cream

  • NDC Code(s): 72839-295-01
  • Packager: Derma Care Research Labs, LLC
  • 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 July 24, 2023

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

  • ACTIVE INGREDIENT

    Glycerin 14.4%, Lidocaine 5%, Petrolatum 15%, Phenylephrine HCl 0.25%

  • PURPOSE

    Anorectal/Hemorrhoidal

  • INDICATIONS & USAGE

    For the 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 the relief of anorectal discomforts. Temporarily protects the inflamed, irritated anorectal surface to help make bowel movements less painful.

  • WARNINGS

    For external and/or intrarectal use.

    Ask a doctor before use if you have: heart disease, high blood pressure, thyroid disease, diabetes, or difficulty in urination due to enlargement of the 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 recommended dosage unless directed by a doctor.

    Stop use and ask a doctor if condition worsens or does not improve within seven (7) days, bleeding occurs, an allergic reaction develops, the symptom being treated does not subside or if redness, irritation, swelling, pain or other symptoms develop or increase.

  • PREGNANCY OR BREAST FEEDING

    Ask a health care professional before use.

  • KEEP OUT OF REACH OF CHILDREN

    If swallowed, seek medical help or contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    Adults: when practical, cleanse area with mild soap and warm water and rinse thoroughly. Gently dry by patting or blotting with toilet tissue or soft cloth before applying. 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: consult a doctor.

    For intrarectal use: attach applicator to tube. Lubricate well, then gently insert applicator into the rectum. Thoroughly cleanse applicator after use with mild soap and warm water and rinse thoroughly.

  • INACTIVE INGREDIENT

    Aesculus hippocastanum (horse chestnut) extract, aloe barbadensis leaf extract, BHA, calendula officinalis extract, cellulose gum, centella asiatica extract, cetyl alcohol, citric acid, disodium EDTA, ethylhexylglycerin, glyceryl stearate, hamamelis virginiana (witch hazel) leaf extract, mineral oil, panthenol, phenoxyethanol, propyl gallate, propylene glycol, sorbitan olivate, steareth-21, stearyl alcohol, tocopherol, tocopheryl acetate, water, xanthan gum.

  • PRINCIPAL DISPLAY PANEL

    Carton

  • INGREDIENTS AND APPEARANCE
    REVIVOL HEMORRHOID AND FISSURE 
    glycerin 14.4%, lidocaine 5%, petrolatum 15%, phenylephrine hcl 0.25% cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72839-295
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE5 g  in 100 g
    PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM15 g  in 100 g
    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
    Inactive Ingredients
    Ingredient NameStrength
    CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
    HAMAMELIS VIRGINIANA LEAF (UNII: T07U1161SV)  
    HORSE CHESTNUT (UNII: 3C18L6RJAZ)  
    CENTELLA ASIATICA TRITERPENOIDS (UNII: 4YS74Q4G4J)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    SORBITAN OLIVATE (UNII: MDL271E3GR)  
    STEARETH-21 (UNII: 53J3F32P58)  
    WATER (UNII: 059QF0KO0R)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    PROPYL GALLATE (UNII: 8D4SNN7V92)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72839-295-011 in 1 CARTON05/12/2023
    142.5 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalM01505/12/2023
    Labeler - Derma Care Research Labs, LLC (116817470)
    Registrant - Derma Care Research Labs, LLC (116817470)
    Establishment
    NameAddressID/FEIBusiness Operations
    Derma Care Research Labs, LLC116817470manufacture(72839-295)