Label: FAMILY WELLNESS- glycerin, phenylephrine hcl, pramoxine hcl, petrolatum cream

  • NDC Code(s): 69571-004-01, 69571-004-02
  • Packager: FRONT PHARMACEUTICAL PLC
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated October 26, 2023

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • ACTIVE INGREDIENT

    Active ingredients (in each gram)

    Glycerin 14.4%

    Phenylephrine HCL 0.25%

    Pramoxine HCL 1%

    White petrolatum 15%

  • PURPOSE

    Purpose

    Protectant

    Vasoconstrictor

    Local anesthetic

    Protectant

  • 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
  • WARNINGS

    Warnings

    . For external use only

    When using this product

    Ask a doctor before use if you have

    •heart disease  •high blood pressure  •thyroid disease  •diabetes

    •trouble urinating due to an enlarged prostate gland

    you are presently taking a prescription Ask a doctor or pharmacist before use if

    drug for high blood pressure.

    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 ir redness, irritation, swelling,

    pain or other symptoms develop or increase. Some people can develop allergic

    reactions to ingredients in this product.

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

    • 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
  • KEEP OUT OF REACH OF CHILDREN

    . If swallowed, get medical help or contact a Keep out of reach of children

    Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    Adults: Directions

    -when practical, cleanse the affected area with mild soap and warm water and

    rinse thoroughly. Gentlydry 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 r

    in the morningor after each bowel movement.

    hildren under 12 years of age: consult a doctor.

  • STORAGE AND HANDLING

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

  • INACTIVE INGREDIENT

    aloe barbadensis leaf extract, Inactive ingredients

    carboxymethylcellulose sodium, cetyl alcohol, glyceryl monostearate,

    methylparaben, paraffin, propylene glycol, propylparaben, stearic acid, tween 80,

    water, xanthan gum

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    FAMILY WELLNESS 
    glycerin, phenylephrine hcl, pramoxine hcl, petrolatum cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69571-004
    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)  
    PARAFFIN (UNII: I9O0E3H2ZE)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69571-004-021 in 1 BOX03/14/2017
    1NDC:69571-004-0126 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01503/14/2017
    Labeler - FRONT PHARMACEUTICAL PLC (530897792)
    Establishment
    NameAddressID/FEIBusiness Operations
    FRONT PHARMACEUTICAL PLC530897792manufacture(69571-004)