Label: MUSCLE BALM (menthol, unspecified form, camphor- synthetic ointment

  • NDC Code(s): 66902-142-63
  • Packager: Natural Essentials, Inc.
  • 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 May 31, 2022

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  • Active ingredients

    Camphor 11 %

    Menthol 11%

  • Purpose

    Topical Analgesic

    Topical Analgesic

  • Uses

    For the temporary relief of minor aches and pains of muscles and joints associated with:

    • Over-Exertion
    • Simple backache
    • Arthritis
    • Strains
    • Sprains
  • Warnings

    For external use only.

    When using this product

    • avoid contact with eyes or mucous membranes
    • do not apply to open wounds or damaged skin
    • do not bandage or use a heating pad

    Stop use and ask a doctor if

    • condition worsens
    • severe skin irritation occurs
    • pain persists for more than 7 days
    • pain clears up then recurs a few days later

    Keep out of reach of children. If swallowed, get medical help or contact Poison Control Center immediately.

    If pregnant or breastfeeding, ask a health professional before use.

  • Directions

    Adults and children 12 years of age and over: rub on affected area; repeat 3 to 4 times daily

    Children under 12 years of age: consult doctor before use.

  • Other Information

    This product may cause allergic reaction in some individuals. Test on small area before use.

  • Inactive ingredients

    Cajeput Oil, Cassia Oil, Clove Oil, Dementholized Mint Oil, Paraffin, Petrolatum

  • Principal Display Panel – 18 g Jar Label

    NATURE'S OIL
    Muscle Balm

    Intense Strength

    Muscle Relieving Ointment

    Net wt 0.63 oz (18 g)

    Figure
  • INGREDIENTS AND APPEARANCE
    MUSCLE BALM 
    menthol, unspecified form, camphor (synthetic) ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66902-142
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM110 mg  in 1 g
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)110 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    CAJUPUT OIL (UNII: J3TO6BUQ37)  
    CHINESE CINNAMON OIL (UNII: A4WO0626T5)  
    CLOVE OIL (UNII: 578389D6D0)  
    PEPPERMINT OIL TERPENELESS (UNII: 4CA0UO1N3Z)  
    PARAFFIN (UNII: I9O0E3H2ZE)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:66902-142-6318 g in 1 JAR; Type 0: Not a Combination Product05/31/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34805/31/2022
    Labeler - Natural Essentials, Inc. (947484713)
    Establishment
    NameAddressID/FEIBusiness Operations
    NATURAL ESSENTIALS, INC.947484713MANUFACTURE(66902-142)
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