Label: BRONCO RUB- camphor eucalyptus menthol ointment

  • NDC Code(s): 66513-220-14
  • Packager: Distribuidora de Alimentos Naturales y Nutricionales, S.A. de C.V
  • 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 October 14, 2022

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  • Active Ingredients

    Camphor 4.8%

    Eucalyptus 1.2%

    Menthol 2.6%

  • Purpose

    Cough Suppressant/Topical Anlagesic

    Cough Suppressant

    Cough Suppressant/Topical Anlagesic

  • Uses

    • on chest and throat, temporarily relieves cough due to common cold • temporarily relieves minor aches and pains of muscles and joints

  • Warnings

    For external use only. Avoid contact with eyes.

  • Do not use

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

  • Ask a doctor before use if you have

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

  • When using this product do not

    • heat • microwave • use near an open flame • add to hot water or any container where heating water. May cause splattering and result in burns.

  • Stop use and ask a doctor if

    • muscle aches and pains worsen, persist for more than 7 days or come back within a few days • cough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache. These could be signs of a serious condition

  • If pregnant or breast feeding

    ask a health professional before use.

  • Keep out of reach of children

    If swallowed get medical help or contact a Poison Control Center immediately.

  • Directions

    see important warnings under "When using this product" section

    •adults and children 2 years and over rub a thick layer on chest and throat or rub on sore aching muscles •cover with a warm, dry cloth if desired • keep clothing loose about throat/chest to help vapors reach the nose/mouth • repeat up to three times per 24 hours or as directed by doctor • children under 2 years: do not use

  • Other information

    • store at room temperature

  • Inactive ingredients

    Petrolatum and Turpentine oil

  • Package label

    image description

  • INGREDIENTS AND APPEARANCE
    BRONCO RUB 
    camphor eucalyptus menthol ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66513-220
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)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) MENTHOL2.6 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    PETROLATUM (UNII: 4T6H12BN9U)  
    TURPENTINE OIL (UNII: C5H0QJ6V7F)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:66513-220-1439 g in 1 JAR; Type 0: Not a Combination Product08/15/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalM01208/15/2014
    Labeler - Distribuidora de Alimentos Naturales y Nutricionales, S.A. de C.V (814400404)
    Establishment
    NameAddressID/FEIBusiness Operations
    Distribuidora de Alimentos Naturales y Nutricionales, S.A. de C.V814400404manufacture(66513-220)
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