Label: CRAMERGESIC- menthol, methyl salicylate ointment

  • NDC Code(s): 59316-998-96, 59316-998-97
  • Packager: Performance Health, LLC
  • 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 7, 2022

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  • Drug Facts

  • Active Ingredients

    Menthol 1.9%

    Methyl Salicylate 13.7%

    Purpose

    Counterirritant

  • Uses

    For the temporary relief of minor aches and pains of muscles and joints associated with strains, sprains, bruises, simple backache, and arthritis. Combined with stretching and calisthenics, Cramergesic assists in the warm-up process, especially in cool, damp weather. Do not bandage tightly.

  • Warnings

    For external use only.
    Use only as directed. In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately. Do not apply to wounds or damaged skin. Avoid contact with the eyes. If condition worsens, or if the symptoms persist for more than 7 days, or clear up and occur again within a few days, discontinue use and consult a doctor. Consult a doctor before administering to children, including teenagers, with chicken pox or flu.

    Keep this and all drugs out of the reach of children

    to avoid accidental poisoning.

  • Directions

    Gently massage into painful area. Adults and children 6 years of age and older: apply to affected area not more than 3 - 4 times daily. Children under 6 years of age: consult a doctor. To apply Cramergesic pack: spread 1/8 " layer of Cramergesic over area. Do not bandage tightly.

  • Other information

    Discontinue use if excessive irritation of skin develops. Use with caution on fair skin. Store in a cool, dry place with cap closed tightly.

  • Inactive Ingredients

    Lanolin, Paraffin, Petrolatum

  • Questions?

    (800) 345-2231

  • Package Labeling:

    Label3

  • INGREDIENTS AND APPEARANCE
    CRAMERGESIC 
    menthol, methyl salicylate ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59316-998
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL1.9 g  in 100 g
    METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE13.7 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    PARAFFIN (UNII: I9O0E3H2ZE)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    LANOLIN (UNII: 7EV65EAW6H)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59316-998-96454 g in 1 JAR; Type 0: Not a Combination Product05/19/201712/31/2024
    2NDC:59316-998-972268 g in 1 JAR; Type 0: Not a Combination Product05/19/201712/31/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34805/19/201712/31/2024
    Labeler - Performance Health, LLC (794324061)
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