Label: AVEDANA MEDICATED CHEST RUB- camphor eucalyptus menthol ointment

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 January 18, 2023

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  • Active Ingredients

    Ingredients                   Purpose

    Camphor 4.8%             cough suppressant/topical analgesic

    Eucalyptus Oil 1.2%      cough suppressant

    Menthol 2.6%               cough supressant/topical analgesic

  • Uses

    Uses - On chest and throat, temporarily relieves cough due to common cold.  On the muscles and joints, temporarily relieves minor aches and pains.

  • Warnings

    Warnings

    For external use only.  Avoid contact with eyes.

  • Do Not Use

    Do not use - by mouth - in nostrils - on wounds or damaged skin - with tight bandages

  • Ask a doctor before use if you have

    asthma - excessive phlegm (mucus) - emphysema - persistent or chronic cough - cough associated with smoking

  • If pregnant or breast-feeding

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

  • Keep out of reach of children

    In case of accidental ingestion, get medical help or contact Poison Control Center immediately.

  • Directions

    - children under 2 years of age, ask a doctor before using the product - adults and children 2 years and older: rub a thick layer on throat and chest or rub on sore aching muscles.  If desired cover with a dry soft cloth, but keep clothing loose.  Repeat up to 3 times a day.

  • Other information

    store at room temperature

  • Other Ingredients

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

  • Purpose

    cough suppressant / topical analgesic, cough suppressant

  • Product Label

    Label

  • INGREDIENTS AND APPEARANCE
    AVEDANA MEDICATED CHEST RUB 
    camphor eucalyptus menthol ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43749-110
    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) 91.05 g  in 100 g
    NUTMEG OIL (UNII: Z1CLM48948) 0.15 g  in 100 g
    TURPENTINE (UNII: XJ6RUH0O4G) 0.05 g  in 100 g
    CEDAR LEAF OIL (UNII: BJ169U4NLG) 0.05 g  in 100 g
    MINERAL OIL (UNII: T5L8T28FGP) 0.05 g  in 100 g
    THYMOL (UNII: 3J50XA376E) 0.05 g  in 100 g
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:43749-110-04113 g in 1 JAR; Type 0: Not a Combination Product09/03/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34809/03/2014
    Labeler - Unipack LLC (009248480)
    Registrant - Unipack LLC (009248480)
    Establishment
    NameAddressID/FEIBusiness Operations
    Unipack LLC009248480manufacture(43749-110)
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