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Vaporizing Chest Rub (Universal Distribution Center LLC)

Available Formats

Dosage Form Package Information Links
GEL 50 g in 1 BOTTLE, PLASTIC (52000-012-08) Label Information
GEL 100 g in 1 BOTTLE, PLASTIC (52000-012-10) Label Information
GEL 56.6 g in 1 BOTTLE, PLASTIC (52000-012-09) Label Information
GEL 226 g in 1 BOTTLE, PLASTIC (52000-012-14) Label Information
GEL 150 g in 1 BOTTLE, PLASTIC (52000-012-12) Label Information
GEL 113 g in 1 BOTTLE, PLASTIC (52000-012-11) Label Information
GEL 170 g in 1 BOTTLE, PLASTIC (52000-012-13) Label Information

Complete Vaporizing Chest Rub Information

  • ACTIVE INGREDIENT

    Active Ingredients

    Camphor            4.7%

    Menthol             1.0%

    Eucalyptus Oil   1.0%


  • PURPOSE

    Purpose

    Decongestant


  • INDICATIONS & USAGE

    Uses

    • on chest and throat, helps temporarily relive cough due to common cold.
    • on joints and muscles, temporarily relives minor aches and pains.

  • WARNINGS

    Warnings

    For external use only; avoid contact with eyes.


  • DO NOT USE

    Do not use

    • by mouth
    • in nostrils
    • with tight bandages
    • on wounds or damaged skin

  • ASK DOCTOR

    Ask doctor before use if you have,

    • cough that occurs with too much phlegm (mucus)
    • persistent or chronic cough such as occurs with asthma, emphysema, or smoking

  • WHEN USING

    When using this product, do not

    • heat
    • microwave
    • add to hot water or any container where heating water. May cause splattering and results in burns

  • STOP USE

    Stop use and ask a doctor if

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

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of the reach of children

    If ingested get medical help or contact a Poison control center immediately


  • DOSAGE & ADMINISTRATION

    Directions

    • adults and children 2 years and over
    • rub a thick layer on chest and throat or rub on sore aching muscles
    • keep clothing loose around chest/throat to help vapors reach the nose/mouth

    • repeat up to 3 times per 24 hours or as directed by doctor
    • do not use on children under 2 years unless directed by doctor

  • INACTIVE INGREDIENT

    Inactive ingredients

    cedar oil, nutmeg oil, paraffin, petrolatum, thymol, turpentine oil


  • SPL UNCLASSIFIED SECTION

    PRINCIPAL DISPLAY PANEL

    VAPORISING CHEST RUB
    NASAL DECONGESTANT AND COUGH SUPPRESSANT
    NET WT.4 OZ (113g)


  • INGREDIENTS AND APPEARANCE
    VAPORIZING CHEST RUB 
    menthol and camphor and eucalyptus oil gel
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:52000-012
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC) 4.7 g  in 100 g
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 1 g  in 100 g
    EUCALYPTUS OIL (UNII: 2R04ONI662) (EUCALYPTUS OIL - UNII:2R04ONI662) EUCALYPTUS OIL 1 g  in 100 g
    Inactive Ingredients
    Ingredient Name Strength
    CEDAR LEAF OIL (UNII: BJ169U4NLG)  
    NUTMEG OIL (UNII: Z1CLM48948)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    THYMOL (UNII: 3J50XA376E)  
    TURPENTINE OIL (UNII: C5H0QJ6V7F)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:52000-012-08 50 g in 1 BOTTLE, PLASTIC
    2 NDC:52000-012-09 56.6 g in 1 BOTTLE, PLASTIC
    3 NDC:52000-012-10 100 g in 1 BOTTLE, PLASTIC
    4 NDC:52000-012-11 113 g in 1 BOTTLE, PLASTIC
    5 NDC:52000-012-12 150 g in 1 BOTTLE, PLASTIC
    6 NDC:52000-012-13 170 g in 1 BOTTLE, PLASTIC
    7 NDC:52000-012-14 226 g in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part341 03/15/2013
    Labeler - Universal Distribution Center LLC (019180459)
    Registrant - Anicare Pharmaceuticals Pvt. Ltd (916837425)
    Establishment
    Name Address ID/FEI Business Operations
    Jell Pharmaceuticals Pvt. Ltd. 726025211 manufacture(52000-012)
    Establishment
    Name Address ID/FEI Business Operations
    Anicare Pharmaceuticals Pvt. Ltd 916837425 manufacture(52000-012)