Label: VICKS VAPORUB- camphor, eucalyptus oil, and menthol oilment 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 December 28, 2017

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  • ACTIVE INGREDIENT

    Active Ingredients:

    Camphor 4.8 %

    Eucalyptus oil 1.2%

    Menthol 2.63%

  • PURPOSE

    Cough suppressant & topical analgesic,

    Cough suppressant

  • DOSAGE & ADMINISTRATION

    * On Chest and throat, temporarily relieves cough due to common cold

    * On Muscles and joins, temporarily relieves minor aches and pains

  • WARNINGS

    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 DOCTOR

    Ask A doctor use if you have:

    *cough that occurs with too much phlegm (mucus)

    *Persistent or chronic such as occurs with smoking, asthma or emplysema

  • WHEN USING

    When use this product, do not

    * HEat

    * Microware

    * Add to hot water or any container where heating water.

    May cause splattering and result in burns

  • PREGNANCY OR BREAST FEEDING

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

  • KEEP OUT OF REACH OF CHILDREN

    Keep Out Of reach of children

  • INDICATIONS & USAGE

    Directions:

    See important warnings under when using this product

    • adults and children 2 years and over:
    1. RUB A THICK LAYER ON CHEST & THROAT OR RUB ON SORE ACHING MISCLES
    2. Cover with a warm, dry cloth if desired
    3. Keep clothing loose abouth throat/chest to help vapors reach the nose/ mouse
    4. repeat up three times per 24 hours or as directed by doctor
    5. children under 2 yearsL do not use.
  • INACTIVE INGREDIENT

    Inactive ingredients:

    Cedarleaf oil, nutmeg oil, special petrolatum, thymol, turpentine oil.

  • PRINCIPAL DISPLAY PANEL

    Net Wt 3.52 Oz 100Gr

  • INGREDIENTS AND APPEARANCE
    VICKS VAPORUB 
    camphor, eucalyptus oil, and menthol oilment ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69772-390
    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
    CEDAR LEAF OIL (UNII: BJ169U4NLG)  
    NUTMEG OIL (UNII: Z1CLM48948)  
    THYMOL (UNII: 3J50XA376E)  
    TURPENTINE OIL (UNII: C5H0QJ6V7F)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69772-390-01100 g in 1 JAR; Type 0: Not a Combination Product11/24/2016
    2NDC:69772-390-0250 g in 1 JAR; Type 0: Not a Combination Product11/24/2016
    3NDC:69772-390-0312 g in 1 JAR; Type 0: Not a Combination Product11/24/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34111/24/2016
    Labeler - Genesis Imports & Exports (078760958)
    Registrant - Teresa Cecena (078760958)
    Establishment
    NameAddressID/FEIBusiness Operations
    Genesis Imports & Exports LLC078760958relabel(69772-390)
    Establishment
    NameAddressID/FEIBusiness Operations
    procter & Gamble Manufactura S De RL De CV812807550manufacture(69772-390)
    Establishment
    NameAddressID/FEIBusiness Operations
    Roir SA de CV812825434relabel(69772-390)
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