Label: ASTONEA CHEST RUB (camphor- synthetic, eucalyptus oil, and 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 September 7, 2022

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredients

    Camphor 4.7%

    Menthol 1.25%

    Eucalyptus oil 1.2%

    Purpose

    Cough suppressant & Topical Analgesic

    Cough suppressant

    Cough suppressant & Topical Analgesic

  • Uses

    • when applied to chest and throat, temporarily relieves cough due to minor throat and bronchial irritation associated with the common cold
    • when applied to muscles and joints, temporarily relieves minor aches and pains of muscles and joints
  • Warnings

    For external use only; avoid contact with eyes.

    Do not use

    • by mouth
    • with tight bandages
    • in nostrils
    • 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
    • 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 persist more than 7 days or come back
    • cough lasts for more than 7 days, comes back, or occurs with fever, rash, or persistent headache. A persistent cough may be a sign 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 right away.

  • Directions

    see important warnings under " When using this product"

    • adults and children 2 years and over
    • rub a thick layer on throat & chest &
    • cover with a warm, dry cloth if desired
    • keep clothing loose about throat and chest to help vapors reach the nose and mouth
    • use up to three times daily or as directed by doctor
    • for muscle/joint minor aches and pains apply to affected area not more than 3 to 4 times daily
    • children under 2 years: do not use
  • Other information

    • store at room temperature
  • Inactive ingredients

    cedar leaf oil, methylparaben, nutmeg oil, petrolatum, propylparaben, thymol, turpentine oil

  • PRINCIPAL DISPLAY PANEL

    Principal Display and Drug Fact Panel

  • INGREDIENTS AND APPEARANCE
    ASTONEA CHEST RUB 
    camphor (synthetic), eucalyptus oil, and menthol ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77338-321
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)0.047 g  in 1 g
    EUCALYPTUS OIL (UNII: 2R04ONI662) (EUCALYPTUS OIL - UNII:2R04ONI662) EUCALYPTUS OIL0.012 g  in 1 g
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL0.0125 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    CEDAR LEAF OIL (UNII: BJ169U4NLG)  
    NUTMEG OIL (UNII: Z1CLM48948)  
    THYMOL (UNII: 3J50XA376E)  
    TURPENTINE OIL (UNII: C5H0QJ6V7F)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:77338-321-21113 g in 1 JAR; Type 0: Not a Combination Product04/08/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34104/05/2019
    Labeler - ASTONEA LABS PRIVATE LIMITED (878533295)
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