Label: MENTHOL CAMPHOR VAPOR RUB (camphor- natural and menthol, unspecified form 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 August 29, 2019

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    ACTIVE INGREDIENTSPURPOSE
    CAMPHOR 5.0%ANTITUSSIVE
    MENTHOL 2.8%ANTITUSSIVE
  • Use

    temporarily relieves cough as may occur or associated with a cold.

  • Warnings

    For external use only.

    Do not use

    • for persistent or chronic cough as occurs with smoking, asthma, or emphysema
    • if cough is accompanied by excessive phlegm (mucous) unless directed by a physician.

    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
    • take by mouth
    • place in nostrils.

    Stop use and ask a doctor if

    • cough persists for more than 1 week
    • cough tends to recur
    • cough is accompanied by a fever, rash or persistent headache. A persistent cough may be a sign of a serious condition.

    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 or older
      • rub on the throat and chest in a thick layer
      • cover with a warm, dry cloth if desired
      • Clothing should be loose about throat and chest to help vapors reach the nose and mouth
      • Use up to 3 times daily or as directedby a doctor
    • children under 2 years of age: Ask a doctor.
  • Other information

    Store away from children at 68-77°F

  • Inactive ingredients

    beeswax, hydrogenated soybean oil, hydrogenated soybean wax.

  • QUESTIONS

    For adverse reactions call 1-888-384-1945

  • PRINCIPAL DISPLAY PANEL - 59 g Jar Box

    99% NATURAL

    ESTD J.R. 1868
    WATKINS
    REMEDIES FOR BODY™

    VAPOR RUB

    MENTHOL CAMPHOR

    COUGH RELIEVING OINTMENT

    NET WT. 2.1 OZ (59 g)

    PRINCIPAL DISPLAY PANEL - 59 g Jar Box
  • INGREDIENTS AND APPEARANCE
    MENTHOL CAMPHOR VAPOR RUB 
    camphor (natural) and menthol, unspecified form ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72342-070
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAMPHOR (NATURAL) (UNII: N20HL7Q941) (CAMPHOR (NATURAL) - UNII:N20HL7Q941) CAMPHOR (NATURAL)5 g  in 100 g
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM2.8 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    Hydrogenated Soybean Oil (UNII: A2M91M918C)  
    Yellow Wax (UNII: 2ZA36H0S2V)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72342-070-591 in 1 BOX09/01/2019
    159 g in 1 JAR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34809/01/2019
    Labeler - J.R. Watkins, LLC. (081071049)
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