Label: CHESTRUB- camphor (synthetic), menthol and eucalyptus oil ointment

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated 12/13

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    Active Ingredients

    Camphor 4.7%

    Menthol 1.0%

    Eucalyptus Oil 1.0%


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  • PURPOSE

    PURPOSE

    Cough Suppressant

    Nasal Decongestant

    Topical Anlagesic

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  • INDICATIONS & USAGE

    Uses

    Temporarily relieves symptoms associated with the common cold:

    • cough 
    • nasal congestion
    • chest congestion

    Temporarily relieves minor aches and pains of muscles


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  • DOSAGE & ADMINISTRATION

    Directions

    See important warnings under "Do not Use this product"

    • Children under 2 years of age, ask a doctor
    • Adults and children 2 years of age and older: rub a thick layer on chest and throat. If desired loosely cover with a soft cloth but keep clothing loose.
    • Repeat up to 3 times daily, or as directed by a doctor
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  • WARNINGS

    Warnings: For external use only. Avoid contact with eyes.

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  • ASK DOCTOR

    Ask a doctor before use if you have: Chronic cough that lasts or occurs with smoking, asthma or emphysema.

    Cough with excessive phlegm (mucus).

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  • DO NOT USE

    Do not use this product; Near an open flame. By adding water. By mouth. In a microwave oven. On wounds or damaged skin. With tight bandages. In nostrils. added to hot water or any container where you are heating water. May cause splattering and result in burns.

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  • STOP USE

    Stop use and ask a doctor if: Muscle aches and pains persist for more than 7 days comes back, or occurs with fever, rash or headache that lasts.

    These could be signs of a serious condition. If pregnant or breast-feeding consult a physician before use.

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  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed get medical help or contact a Poison Control Center immediately.

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  • INACTIVE INGREDIENT

    Inactive Ingredients:

    Petrolatum, Nutmeg Oil, Turpentine Oil, Cedar Leaf Oil, Thymol, Paraffin

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  • PRINCIPAL DISPLAY PANEL

    Package Label

    image of package label

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  • INGREDIENTS AND APPEARANCE
    CHESTRUB 
    camphor menthol eucalyptus oil ointment
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:20276-100
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    CAMPHOR (SYNTHETIC) (CAMPHOR (SYNTHETIC)) CAMPHOR (SYNTHETIC) 4.7 g  in 100 g
    MENTHOL (MENTHOL) MENTHOL 1 g  in 100 g
    EUCALYPTUS OIL (EUCALYPTUS OIL) EUCALYPTUS OIL 1 g  in 100 g
    Inactive Ingredients
    Ingredient Name Strength
    CEDAR LEAF OIL  
    NUTMEG  
    PARAFFIN  
    PETROLATUM  
    THYMOL  
    TURPENTINE  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:20276-100-31 113 g in 1 JAR
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part348 11/15/2009
    Labeler - Delta Brands Inc (102672008)
    Establishment
    Name Address ID/FEI Business Operations
    Anicare Pharmaceuticals Pvt Ltd 916837425 manufacture(20276-100)
    Establishment
    Name Address ID/FEI Business Operations
    Ningbo Pulisi Daily Chemical Products Co., Ltd. 529047265 manufacture(20276-100)
    Establishment
    Name Address ID/FEI Business Operations
    Jell Pharmaceuticals Pvt. Ltd. 726025211 manufacture(20276-100)
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