Label: COLD RUB- camphor eucalyptus oil menthol ointment

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by 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 May 30, 2010

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  • ACTIVE INGREDIENT

    Active Ingredients
    Camphor 4.8%
    Eucalyptus oil 1.2%
    Menthol 2.8%

  • PURPOSE

    PURPOSE

    cough suppressant/topical analgesic
    nasal decongestant/cough suppressant
    cough suppressant/topical analgesic

  • INDICATIONS & USAGE

    Uses

    Temporarily relief for throat and chest

    • Cough 
    • Nasal congestion due to common cold
    • Aching muscles
    • Minor aches and pains
  • WARNINGS

    Warning
    For external use only. Avoid contact with eyes.
  • DO NOT USE

    Do not use
    • by mouth
    • in nostrils
    • on wounds or damaged skin
    • with light bandages
  • ASK DOCTOR

    Ask a doctor before use if you have

    • Asthma
    • Excessive phlegm (mucus)
    • Emphysema
    • Persistent or chronic cough
    • Cough associated with smoking
  • PREGNANCY OR BREAST FEEDING

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

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If case of accidental ingestion, get medical help or contact a Poison Control Center immediately.

  • DOSAGE & ADMINISTRATION

    Directions

    • See important warnings under "When using product"
    • Children under 2 years of age, ask a doctor before using the product
    • Adults and children 2 years of age and older: rub a thick layer chest and throat or sore aching muscles. If desired loosely cover with a soft cloth but keep clothing loose. Repeat up to 3 times daily

  • SPL UNCLASSIFIED SECTION

    Other Information
    • Store at room temperature
  • INACTIVE INGREDIENT

    Other Ingredients
    Cedar leaf Oil, Mineral Oil, Nutmeg Oil, Petrolatum, Spirits of Turpentine, Thymol
  • PRINCIPAL DISPLAY PANEL

    Package Label

    image of package label

  • INGREDIENTS AND APPEARANCE
    COLD RUB 
    camphor eucalyptus oil menthol ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51444-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAMPHOR (NATURAL) (UNII: N20HL7Q941) (CAMPHOR (NATURAL) - UNII:N20HL7Q941) CAMPHOR (NATURAL)4.8 g  in 100 g
    EUCALYPTUS OIL (UNII: 2R04ONI662) (EUCALYPTUS OIL - UNII:2R04ONI662) EUCALYPTUS OIL1.2 g  in 100 g
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL2.8 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    CEDAR LEAF OIL (UNII: BJ169U4NLG)  
    NUTMEG (UNII: AEE24M3MQ9)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    THYMOL (UNII: 3J50XA376E)  
    TURPENTINE (UNII: XJ6RUH0O4G)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51444-001-38108 g in 1 JAR
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34106/15/2010
    Labeler - JMD All Star Impex Inc. (962316662)
    Establishment
    NameAddressID/FEIBusiness Operations
    Steller Mercantile Pvt.Ltd.650493005manufacture
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