VAPORIZING CHEST RUB (MENTHOL AND CAMPHOR AND EUCALYPTUS OIL) GEL [SINGHFAM CORPORATION]

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VAPORIZING CHEST RUB (MENTHOL AND CAMPHOR AND EUCALYPTUS OIL) GEL [SINGHFAM CORPORATION]
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NDC 52920-124-04
Set ID 78aee8fb-7441-463c-bbe7-513dddcbc0f1
Category HUMAN OTC DRUG LABEL
Packager Singhfam Corporation
Generic Name
Product Class
Product Number
Application Number PART341
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  • Active Ingredients

    Menthol 2.0%

    Camphor 4.7%

    Eucalyptus Oil 1.0%

  • Purpose

    Decongestant

  • USES:

    • On chest and throat for temporary relief of nasal congestion and cough due to common cold.
    • On muscles and joints for temporary relief of minor aches and pains.
  • Warnings:

    • For external use only
    • Avoid contact with eyes

    Keep out of reach of children

    if swallowed, seek medical attention or contact a poison control center immediately.

    If pregnant or breast-feeding,

    consult your doctor before use.

    Do not use

    near mouth, in nose, with tight bandages, on wounds or damaged skin.

    Consult a doctor before use

    if you have a cough with too much phlegm/mucus; persistent or chronic cough associated with asthma, emphysema or smoking.

    when using this product,

    do not heat, microwave, add to hot water or any container in which water is heating as splattering may occur resulting in burns.

    Discontinue use and consult a doctor

    if you experience:

    • recurring or persistent Cough that lasts for more than 7 days or occurs with fever, rash or headache.
    • recurring or persistent muscle or joint aches and pains.

    These symptoms may be a sign of a serious condition.

  • Directions:

    • For adults and children 2 years of age and over.
    • Apply a thick layer on throat and chest or rub on sore muscles and joints.
    • Cover loosely with a warm dry cloth if desired.
    • Keep clothing loose around throat and chest to allow vapors to reach the nose and mouth.
    • Apply no more than 3 times in a 24 hour period or as directed by doctor.
  • Other information:

    Store at room temperature away from heat or flame.

  • Inactive Ingredients:

    Petrolatum, Mineral Oil, Nutmeg Oil, Turpentine Oil, Thymol, Cedar Leaf Oil.

  • PRINCIPAL DISPLAY PANEL

    PRINCIPAL DISPLAY PANEL
    elizabeth style
    Vaporizing Chest Rub
    Nasal Decongestant and Cough Suppressant
    NET WT 4 OZ (113 G)
    PRINCIPAL DISPLAY PANEL - 4 oz

  • INGREDIENTS AND APPEARANCE
    VAPORIZING CHEST RUB 
    menthol and camphor and eucalyptus oil gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52920-124
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)4.7 g  in 113 g
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL1.1 g  in 113 g
    EUCALYPTUS OIL (UNII: 2R04ONI662) (EUCALYPTUS OIL - UNII:2R04ONI662) EUCALYPTUS OIL1.1 g  in 113 g
    Inactive Ingredients
    Ingredient NameStrength
    PETROLATUM (UNII: 4T6H12BN9U)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    NUTMEG OIL (UNII: Z1CLM48948)  
    TURPENTINE OIL (UNII: C5H0QJ6V7F)  
    THYMOL (UNII: 3J50XA376E)  
    CEDAR LEAF OIL (UNII: BJ169U4NLG)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52920-124-04113 g in 1 JAR
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34103/10/2010
    Labeler - Singhfam Corporation (019499958)
    Establishment
    NameAddressID/FEIBusiness Operations
    Anicare Pharmaceuticals Pvt. Ltd.916837425MANUFACTURE(52920-124)
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