FAMILY WELLNESS (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL) OINTMENT [FRONT PHARMACEUTICAL PLC]

FAMILY WELLNESS (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL) OINTMENT [FRONT PHARMACEUTICAL PLC]
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NDC 69571-006-01, 69571-006-02
Set ID cfdd61e3-e12e-491c-b2a8-90fae19e8870
Category HUMAN OTC DRUG LABEL
Packager FRONT PHARMACEUTICAL PLC
Generic Name
Product Class alpha-1 Adrenergic Agonist
Product Number
Application Number PART346
  • ACTIVE INGREDIENT

    Active ingredients (in each gram)

    Mineral oil 14%

    Petrolatum 74.9%

    Phenylephrine HCl 0.25%

  • PURPOSE

    Purposes

    Protectant

    Protectant

    Vasoconstrictor

  • INDICATIONS & USAGE

    Uses •helps relieve the local itching and discomfort associated with hemorrhoids.

    •Temporarily shrinks hemorrhoid tissue and relieves burning.

    •Temporarily provides a coating for relief of anorectal burning.

    •Temporarily protects the inflamed, irritated anorectal surface to help make bowel movements less

    painful

  • WARNINGS

    Warnings

    For external and/or intrarectal use only

    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.

    •introduction of the applicator into the rectum causes additional pain.

    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 and children 12 years of age and older for topical use:

    •clean the affected area, and pat or dab dry before applying ointment.

    •apply to the affected area up to 4 times daily, especially after each bowel movement.

    For intrarectal use:

    •attach included applicator to tube.

    •lubricate applicator tip and gently insert into rectum

    •thoroughly clean applicator after each use, and replace cover

    Children under 12 years of age: ask a doctor before use.

  • OTHER SAFETY INFORMATION

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

  • INACTIVE INGREDIENT

    Inactive ingredients  beeswax, benzoic acid, cetyl alcohol, glycerin, laureth-23,

    methylparaben, propylparaben, stearyl alcohol

  • QUESTIONS

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

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    FAMILY WELLNESS 
    mineral oil, petrolatum, phenylephrine hcl ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69571-006
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MINERAL OIL (UNII: T5L8T28FGP) (MINERAL OIL - UNII:T5L8T28FGP) MINERAL OIL14 g  in 100 g
    PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM74.9 g  in 100 g
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE.25 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    LAURETH-23 (UNII: N72LMW566G)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69571-006-021 in 1 BOX03/30/2017
    1NDC:69571-006-0157 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34603/30/2017
    Labeler - FRONT PHARMACEUTICAL PLC (530897792)
    Establishment
    NameAddressID/FEIBusiness Operations
    FRONT PHARMACEUTICAL PLC530897792manufacture(69571-006)

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