THERAPLUS PLUS (PHENYLEPHRINE HCI) OINTMENT [ZHEJIANG JINGWEI PHARMACEUTICAL CO., LTD.]

THERAPLUS PLUS (PHENYLEPHRINE HCI) OINTMENT [ZHEJIANG JINGWEI PHARMACEUTICAL CO., LTD.]
PDF | XML

NDC 55621-005-01
Set ID edf9f8d5-f55d-4c31-adfb-ba77ca24cc3d
Category HUMAN OTC DRUG LABEL
Packager Zhejiang Jingwei Pharmaceutical Co., Ltd.
Generic Name
Product Class alpha-1 Adrenergic Agonist
Product Number
Application Number PART346
  • INACTIVE INGREDIENT

    Inactive Ingredients beeswax, benzoic acid, cetyl alcohol, glycerin, laureth-23, methylparaben, propylparaben, stearyl alcohol

  • ACTIVE INGREDIENT

    Active Ingredient (in each gram)

    Mineral oil  14%

    Petrolatum  74.9%

    Phenylephrine HCI  0.25%

  • Warnings

    For external and/or intrarectal use only

  • PURPOSE

    Purpose

    Protectant

    Protectant

    Vasoconstrictor

  • 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.


  • 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 discomforts

    -temporarily protects the inflamed, irritated anorectal surface to help make bowel movements less painful

  • DOSAGE & ADMINISTRATION

    Directions

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

    -clean the affected area, and oat 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

  • PREGNANCY OR BREAST FEEDING

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

  • STOP USE

    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

  • ASK 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 DOCTOR/PHARMACIST

    Ask a doctor or pharmacist before use if you are

    -presently taking a prescription drug for high blood pressure

  • PRINCIPAL DISPLAY PANEL

    copy of label

  • INGREDIENTS AND APPEARANCE
    THERAPLUS   PLUS
    phenylephrine hci ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55621-005
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE0.25 g  in 100 g
    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
    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:55621-005-0142 g in 1 TUBE; Type 0: Not a Combination Product03/01/2013
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34603/01/2013
    Labeler - Zhejiang Jingwei Pharmaceutical Co., Ltd. (530876549)
    Establishment
    NameAddressID/FEIBusiness Operations
    Zhejiang Jingwei Pharmaceutical Co., Ltd.530876549manufacture(55621-005)

Related Drugs