Label: COUGH AND COLD THERAPY FOR KIDS- camphor, menthol, eucalyptus oil ointment

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 25, 2023

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  • Active ingredients

    Organic Camphor 4.7%

    Organic Menthol 2.6%

    Organic Eucalyptus Oil 1.2%

  • Purpose

    Organic Camphor 4.7%......................Topical Antitussive

    Organic Menthol 2.6%........................Topical Antitussive

    Organic Eucalyptus Oil 1.2%..............Topical Antitussive

  • Uses

    Temporarily relieves cough associated with the common cold.

  • Warnings

    For external use only

    Do not use

    • by mouth
    • in nostrils

    Ask a doctor before use if you have

    • persistent or chronic cough such as occurs with asthma or if cough is accompanied by excessive phlegm (mucus).

    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.

    Stop use and ask a doctor if

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

    Keep this and all drugs out of the reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

  • Directions

    See important warnings under "When using this product"

    Children 2 years and 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 directed by a doctor

    Children under 2 years of age: Ask a doctor.

  • Other information

    Tamper-evdent. Ensure seal is intact before use.

  • Inactive ingredients

    Organic Beeswax, Organic Coconut Oil, Organic Grapeseed Oil, Organic Jojoba Oil, Organic Kokum Butter, Organic Shea Butter, Vitamin E.

  • PRINCIPAL DISPLAY PANEL

    maple organics

    Plant Based

    Cough & Cold Therapy For Kids

    Soothing & Calming Cough Suppressant

    Net Wt. 2 oz / 56 g

    1

    2

  • INGREDIENTS AND APPEARANCE
    COUGH AND COLD THERAPY FOR KIDS 
    camphor, menthol, eucalyptus oil ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83670-201
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAMPHOR (NATURAL) (UNII: N20HL7Q941) (CAMPHOR (NATURAL) - UNII:N20HL7Q941) CAMPHOR (NATURAL)4.7 g  in 100 g
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL2.6 g  in 100 g
    EUCALYPTUS OIL (UNII: 2R04ONI662) (EUCALYPTUS OIL - UNII:2R04ONI662) EUCALYPTUS OIL1.2 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    GARCINIA INDICA SEED BUTTER (UNII: US2H3D7800)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    JOJOBA OIL (UNII: 724GKU717M)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    GRAPE SEED OIL (UNII: 930MLC8XGG)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83670-201-021 in 1 CARTON09/14/2023
    156 g in 1 JAR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01209/14/2023
    Labeler - Everlaan Organics Inc (243282059)
    Establishment
    NameAddressID/FEIBusiness Operations
    Everlaan Organics Inc243282059manufacture(83670-201)
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