Label: MENTHOLATUM- camphor (synthetic) and menthol ointment 

  • NDC Code(s): 10742-0001-1, 10742-0001-2, 10742-0001-3, 10742-0001-4
  • Packager: The Mentholatum Company
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 06/13

If you are a consumer or patient please visit this version.

  • Active ingredients

    Camphor 9%

    Menthol, natural 1.3%

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  • Purpose

    Camphor - Topical Analgesic

    Menthol, natural - Topical Analgesic

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  • Uses

    temporarily relieves minor aches and pains of muscles and joints

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  • Warnings

    For external use only

    When using this product

    do not heat
    do not microwave
    do not add to hot water or any container where heating water. May cause splattering and result in burns.
    do not get into eyes
    do not apply to wounds or to damaged skin
    do not bandage tightly

    Stop use and ask a doctor if

    condition worsens
    symptoms persist for more than 7 days or clear up and occur again within a few days

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

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  • Directions

    adults and children 2 years and over: apply to affected area not more than 3 to 4 times daily
    children under 2 years: ask a doctor
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  • Inactive ingredients

    fragrance, petrolatum, titanium dioxide

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  • Questions?

    Toll free 1-877-636-2677 MON-FRI 9AM to 5PM (EST)

    www.mentholatum.com

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  • Package/Label Principal Display Panel
  • INGREDIENTS AND APPEARANCE
    MENTHOLATUM 
    camphor, menthol ointment
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:10742-0001
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    CAMPHOR (SYNTHETIC) (CAMPHOR (SYNTHETIC)) CAMPHOR (SYNTHETIC) 90 mg  in 1 g
    MENTHOL (MENTHOL) MENTHOL 13 mg  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    PETROLATUM  
    TITANIUM DIOXIDE  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:10742-0001-1 1 in 1 CARTON
    1 28 g in 1 JAR
    2 NDC:10742-0001-2 1 in 1 CARTON
    2 85 g in 1 JAR
    3 NDC:10742-0001-3 1 in 1 CARTON
    3 28 g in 1 TUBE
    4 NDC:10742-0001-4 1 in 1 CARTON
    4 106.3 g in 1 JAR
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part348 12/13/1976
    Labeler - The Mentholatum Company (002105757)
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