Label: THERACARE MEDICATED CHEST RUB- camphor, menthol, eucalyptus oil 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 March 22, 2023

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  • ACTIVE INGREDIENT

    Active Ingredients:

    Camphor 4.8 %

    Menthol 2.6%

    Eucalyptus oil 1.2%

  • PURPOSE

    Cough suppressant & topical analgesic,

    Cough suppressant

  • INDICATIONS & USAGE

    • Temporarily relieves throat and chest
    • cough
    • Nasal congestion due to common cold
    • aching muscles
    • minor aches and pains
  • Warnings

    For external use only; avoid contact with eyes.

  • Do not use

    • By mouth
    • In nostrils
    • On wounds or damaged skin
    • with tight bandages
  • ASK DOCTOR

    Ask A doctor use if you have:

    • asthma
    • excessive phlegm (mucus)
    • emphysema
    • Persistent or chronic cough
    • cough associated with smoking
  • When using this product, do not

    • heat
    • Microware
    • Use near 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/pain persist more than 7 days or comes back
    • cough lasts more than 7 days, comes back or occurs with fever, rash, or headache that lasts. These could be a sign of a serious condition.

  • If pregnant or breastfeeding

    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 (800-222-1222) right away.

  • Directions:

    See important warnings above

    • children under 2 years of age, ask a doctor before using this product
    • Adults and children 2 years and older, rub a thick layer on chest and throat or rub on sore aching muscles. If desired cover with a dry soft cloth but keep clothing loose. Repeat up to 3 times daily.
  • Other Information

    Store at room temperature

  • Inactive ingredients:

    Cedar leaf oil, nutmeg oil, paraffin, petrolatum, thymol, turpentine oil.

  • TheraCare Medicated Chest Rub

    label

  • INGREDIENTS AND APPEARANCE
    THERACARE MEDICATED CHEST RUB 
    camphor, menthol, eucalyptus oil ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71101-202
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    EUCALYPTUS OIL (UNII: 2R04ONI662) (EUCALYPTUS OIL - UNII:2R04ONI662) EUCALYPTUS OIL0.012 g  in 1 g
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)0.048 g  in 1 g
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL0.026 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    PETROLATUM (UNII: 4T6H12BN9U)  
    CEDAR LEAF OIL (UNII: BJ169U4NLG)  
    NUTMEG OIL (UNII: Z1CLM48948)  
    THYMOL (UNII: 3J50XA376E)  
    TURPENTINE OIL (UNII: C5H0QJ6V7F)  
    PARAFFIN (UNII: I9O0E3H2ZE)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71101-202-01100 g in 1 JAR; Type 0: Not a Combination Product03/01/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34103/01/2023
    Labeler - Veridian Healthcare (830437997)
    Establishment
    NameAddressID/FEIBusiness Operations
    Jell Pharmaceuticals Private Limited726025211manufacture(71101-202)
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