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Medicated (Family Dollar Services Inc)

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CREAM 113 g in 1 JAR (55319-100-01) Label Information

Complete Medicated Information

  • ACTIVE INGREDIENT

    Active ingredients
    Camphor 4.8%
    Menthol 2.6%
    Eucalyptus Oil 1.2%


  • PURPOSE

    Purpose

    Cough suppressant /topical analgesic

    Cough suppressant /topical analgesic

    Cough supressan


  • INDICATIONS & USAGE

    Uses: Temporarily relieves throat and chest

    • cough
    • nasal congestion due to common cold
    • aching muscles
    • minor aches and pains

  • WARNINGS

    Warnings

    For external use only. Avoid contact with eyes


  • DO NOT USE

    Do not use:

    • by mouth
    • by nostrils
    • on wounds or damaged skin
    • with light bandages

  • ASK DOCTOR

    Ask a doctor before use if you have

    • asthma
    • excessive phlem (mucus)
    • emphysema
    • persistent or chronic cough
    • cough associated with smoking

  • WHEN USING

    When using this product do not heat
    • microwave
    • use near open flame
    • add to hot water or any container where heating water may cause splattering and result in burns

  • STOP USE

    Stop use and ask a doctor if

    • muscle aches/pain persist more than more than 7 days or come back
    • cough lasts more than 7 days, comes back, or occurs with fever, rash, or headache that lasts. These could be signs of a serious condition.

  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast feeding, ask a health profesional before use


  • KEEP OUT OF REACH OF CHILDREN

    Keep out reach of children.

    In case of accidental ingestion get medical help or contact a Poison Control Center right away.


  • DOSAGE & ADMINISTRATION

    Directions

    • see important warnings when using this product
    • children under 2 years of age, ask a doctor before using this product
    • adults and children 2 years older, rub a thick layer on chest and and throat or rub on sore,aching muscles. If desired cover with a dry soft cloth but keep clothing loose. Repeat up to 3 times daily

  • SPL UNCLASSIFIED SECTION

    Other information

    • Store at room temperature

  • INACTIVE INGREDIENT

    Inactive ingredients:

    cedar leaf oil, nutmeg oil, paraffin, patrolatum, thymol, turpentine oil


  • PRINCIPAL DISPLAY PANEL

    Medicated chest rub


    4 oz (113 g)




    image of back label

  • INGREDIENTS AND APPEARANCE
    MEDICATED  CHEST RUB
    camphor, menthol, eucalyptus oil cream
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:55319-100
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC) 4.8 g  in 100 g
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 2.6 g  in 100 g
    EUCALYPTUS OIL (UNII: 2R04ONI662) (EUCALYPTUS OIL - UNII:2R04ONI662) EUCALYPTUS OIL 1.2 g  in 100 g
    Inactive Ingredients
    Ingredient Name Strength
    CEDAR LEAF OIL (UNII: BJ169U4NLG)  
    NUTMEG OIL (UNII: Z1CLM48948)  
    PARAFFIN (UNII: I9O0E3H2ZE)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    THYMOL (UNII: 3J50XA376E)  
    TURPENTINE (UNII: XJ6RUH0O4G)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:55319-100-01 113 g in 1 JAR
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part348 07/19/2011
    Labeler - Family Dollar Services Inc (024472631)
    Registrant - Blue Cross Laboratories (008298879)
    Establishment
    Name Address ID/FEI Business Operations
    Blue Cross Laboratories 008298879 manufacture(55319-100)
    Establishment
    Name Address ID/FEI Business Operations
    Anicare Pharmaceuticals Pvt. Ltd 916837425 manufacture(55319-100)