Label: ELECTRIC MEDICATED BALM- menthol and methyl salicylate ointment

  • NDC Code(s): 63299-046-01, 63299-046-04, 63299-046-05
  • Packager: FEI FAH MEDICAL MANUFACTURING PTE LTD
  • 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 November 11, 2019

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  • ACTIVE INGREDIENT

    Active Ingredients
    Menthol 11%
    Methyl salicylate 22%

  • PURPOSE

    Purpose
    External analgesic
    External analgesic

  • INDICATIONS & USAGE

    Uses
    For the temporary relief of minor aches and pains of muscles and joints due to

    • simple backache
    • arthritis
    • strains
    • bruises
    • sprains
  • WARNINGS

    Warnings
    For external use only

  • DO NOT USE

    Do not use

    • on wounds
    • on irritated or damaged skin
    • on the face
    • otherwise than as directed
  • WHEN USING

    When using this product

    • avoid contact with the eyes or mucous membranes
    • do not bandage tightly
  • STOP USE

    Stop use and ask a doctor if

    • condition worsens
    • symptoms persist for more than 7 days
    • symptoms clear up and occur again within a few days
    • excessive irritation of the skin develops
    • nausea, vomiting, abdominal discomfort, diarrhea, or skin rash occurs
    • when using for pain of arthritis
      • pain persists for more than 10 days
      • redness is present
      • in conditions affecting children under 12 years of age
  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children to avoid accidental poisoning
    If swallowed, get medical help or contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    Directions

    • Adults and children 3 years of age and older: Apply a small amount with your finger tip then gently rub into the affected area not more than 3 to 4 times daily.
    • Children under 3 years of age: Do not use, consult your doctor.
  • STORAGE AND HANDLING

    Other information

    • keep container tightly closed
    • store at 15° to 30°C (59° to 86°F)
  • INACTIVE INGREDIENT

    Inactive ingredients   Petrolatum

  • QUESTIONS

    Questions or comments? (888) 221-3496 M-F 9am to 5pm

    • you may also report serious side effects to this phone number
  • PRINCIPAL DISPLAY PANEL

    ELECTRIC MEDICATED BALM
    External Analgesic
    NDC 63299-046-04
    NET 2.45 oz (70g)
    IMAGE OF 70G BOX

  • INGREDIENTS AND APPEARANCE
    ELECTRIC MEDICATED BALM 
    menthol and methyl salicylate ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63299-046
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL11 g  in 100 g
    METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE22 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    PETROLATUM (UNII: 4T6H12BN9U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63299-046-011 in 1 BOX02/13/2008
    119 g in 1 JAR; Type 0: Not a Combination Product
    2NDC:63299-046-041 in 1 BOX02/13/2008
    270 g in 1 JAR; Type 0: Not a Combination Product
    3NDC:63299-046-051 in 1 BOX02/13/2008
    310 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 finalpart34802/13/2008
    Labeler - FEI FAH MEDICAL MANUFACTURING PTE LTD (628416141)
    Establishment
    NameAddressID/FEIBusiness Operations
    FEI FAH MEDICAL MANUFACTURING PTE LTD628416141manufacture(63299-046)
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