Label: MUSCLE FREEZE RELIEF- menthol gel

  • NDC Code(s): 66902-410-03, 66902-410-04, 66902-410-15, 66902-410-16, view more
    66902-410-28, 66902-410-55
  • Packager: NATURAL ESSENTIALS, INC.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 9, 2024

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  • SPL UNCLASSIFIED SECTION

    SHAKE WELL

  • Active ingredient

    Menthol 3.7%

  • Purpose

    Topical Analgesic

  • Uses

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

    • Simple backache
    • Arthritis
    • Strains
    • Bruises
    • Sprains
  • Warnings

    For external use only.

    Flammable:Keep away from fire or flame and heated surfaces

    Do Not Use

    • if you are allergic to any ingredient in this product
    • on open wounds, damaged or irritated skin
    • with a heating pad or TENS device
    • after expiration date

    When using this product

    • do not bandage tightly
    • do not use otherwise than as directed
    • avoid contact with eyes or mucous membranes

    Stop use and ask a doctor if

    • condition worsens
    • rash, itching, redness or excessive irritation of the skin develops
    • symptoms persist for more than 7 days
    • symptoms dear up and occur again within a few days

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

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

  • Directions

    Adults and children 12 years of age and over:

    • apply to affected area no more than 4 times a day
    • massage painful area until absorbed into skin
    • wash hands after each use with cold water

    Children under 12 years of age:consult a doctor.

  • Other Information

    • store in a cool place away from direct sunlight
    • store with cap closed tightly
  • Inactive ingredients

    Aloe Barbadensis Leaf Extract, Arnica Extract, Camphor, Carbomer, Ethylhexylglycerin, Ilex Paraguariensis leaf Extract, Isopropyl Alcohol, Phenoxyethanol, Tea Tree Oil, Tocopheryl Acetate (Vitamin E Acetate), Triethanolamine, Water.

  • Principal Display Panel – 85 g Container Label

    Muscle
    Freeze
    Relief Gel

    Net Wt. 3 oz. (85 g)

    Muscle Freeze Relief Gel - 3 oz

  • Principal Display Panel – 425 g Container Label

    Muscle
    Freeze
    Relief Gel

    Net Wt. 15 oz. (425 g)

    Muscle Freeze Relief Gel - 15 oz

  • Principal Display Panel - 113 g Container Label

    Muscle

    Freeze

    Relief Gel

    Net Wt. 4 oz (113 g) Muscle Freeze Gel - 4 oz

  • INGREDIENTS AND APPEARANCE
    MUSCLE FREEZE RELIEF 
    menthol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66902-410
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM37 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)  
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:66902-410-0385 g in 1 CONTAINER; Type 0: Not a Combination Product07/15/2021
    2NDC:66902-410-04113 g in 1 BOTTLE; Type 0: Not a Combination Product07/15/2021
    3NDC:66902-410-16453 g in 1 BOTTLE; Type 0: Not a Combination Product07/15/2021
    4NDC:66902-410-283629 g in 1 JUG; Type 0: Not a Combination Product07/15/2021
    5NDC:66902-410-55195498 g in 1 DRUM; Type 0: Not a Combination Product07/15/2021
    6NDC:66902-410-15425 g in 1 BOTTLE; Type 0: Not a Combination Product12/07/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01707/15/2021
    Labeler - NATURAL ESSENTIALS, INC. (947484713)
    Establishment
    NameAddressID/FEIBusiness Operations
    NATURAL ESSENTIALS, INC.947484713manufacture(66902-410)
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