Label: MENTHOL CAMPHOR COUGH SUPPRESSANT 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 30, 2019

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active IngredientsPurpose
    CAMPHOR 5.3%EXTERNAL ANALGESIC, ANTITUSSIVE
    MENTHOL 2.8%EXTERNAL ANALGESIC, ANTITUSSIVE
  • Uses

    temporarily relieves

    • minor aches and pains of muscles and joints
    • pain and itching of minor burns, sunburn, minor cuts and scrapes
    • cough associated with a cold
  • Warnings

    For external use only.

    Do not

    • take by mouth or place in nostrils
    • apply to wounds or damaged skin
    • bandage tightly
    • get in eyes.

    Do not use

    • for persistent or chronic cough as occurs with smoking, asthma, or emphysema
    • if cough is accompanied by excessive phlegm unless directed by a physician.
    • near an open flame
    • by adding to hot water
    • in a microwave oven. Improper use may cause the mixture to splatter and cause burns.

    Discontinue use and consult a physician if cough or other symptoms

    • worsen
    • are accompanied by fever, rash or persistent headache
    • persist more than 7 days
    • clear up then recur within a few days

    Keep out of reach of children. In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.

  • Directions

    For adults and children 2 years and older:

    For

    • aches, pains or itching; apply to affected area not more than 3-4 times daily.

    For

    • cough as occurs with cold; apply thick layer to throat and chest. Area of application may be covered with a warm, dry cloth. Clothing should be left loose about the throat and chest to help the vapors rise to reach nose and mouth. Applications may be repeated up to 3 times or as directed by physician. For children under 2 years of age: Consult a physician.
  • Other information

    store away from children at 68-77°F.

  • Inactive ingredients

    paraffin, petrolatum

  • FOR QUESTIONS OR COMMENTS

    CALL 1-888-384-1945

  • PRINCIPAL DISPLAY PANEL - 116 g Jar Box

    • COUGH SUPPRESSANT RUB •

    WITH ALL–NATURAL MENTHOL

    PRINCIPAL DISPLAY PANEL - 116 g Jar Box
  • INGREDIENTS AND APPEARANCE
    MENTHOL CAMPHOR COUGH SUPPRESSANT RUB 
    camphor (natural) and menthol, unspecified form ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72342-010
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAMPHOR (NATURAL) (UNII: N20HL7Q941) (CAMPHOR (NATURAL) - UNII:N20HL7Q941) CAMPHOR (NATURAL)5.3 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
    PARAFFIN (UNII: I9O0E3H2ZE)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72342-010-161 in 1 BOX09/01/2019
    1116 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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