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
  • 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 February 17, 2020

If you are a consumer or patient 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

    • 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 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.

    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.

    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 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

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

  • INACTIVE INGREDIENT

    Inactive ingredients aloe barbadensis leaf extract,

    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 finalpart34603/14/2017
    Labeler - FRONT PHARMACEUTICAL PLC (530897792)
    Establishment
    NameAddressID/FEIBusiness Operations
    FRONT PHARMACEUTICAL PLC530897792manufacture(69571-004)