Label: HEALTHWISE 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 January 11, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredients

    Camphor 4.8%

    Eucalyptus oil 1.2%

    Menthol 2.6%

    Purpose

    Camphor 4.8% Cough suppressant, topical analgesic

    Menthol 2.6% Cough suppressant, topical analgesic

    Eucalyptus oil 1.2% Cough suppressant

  • Uses

    • 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 a doctor before use if you have

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

    When using this product, do not

    • heat
    • microwave
    • 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 or comes back, or occurs with fever, rash, or headache that lasts. 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. In case of accidental ingestion, get medical help or contact a Poison Control Center (800-222-1222) right away.

  • Directions

    see important warnings under " When using this product"

    • children under 2 years of age, ask a doctor before using this product

    adults and children 2 years and over:

    • rub a thick layer on chest & fractor 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

  • PRINCIPAL DISPLAY PANEL - 113 g

    label

  • INGREDIENTS AND APPEARANCE
    HEALTHWISE CHEST RUB 
    camphor (synthetic), eucalyptus oil, and menthol ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71101-205
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)0.048 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) MENTHOL0.026 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    PARAFFIN (UNII: I9O0E3H2ZE)  
    CEDAR LEAF OIL (UNII: BJ169U4NLG)  
    NUTMEG OIL (UNII: Z1CLM48948)  
    THYMOL (UNII: 3J50XA376E)  
    TURPENTINE OIL (UNII: C5H0QJ6V7F)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71101-205-011 in 1 BOX10/01/2021
    1113 g in 1 JAR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34110/01/2021
    Labeler - Veridian Healthcare (830437997)
    Establishment
    NameAddressID/FEIBusiness Operations
    ANICARE PHARMACEUTICALS PRIVATE LIMITED916837425manufacture(71101-205)
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