Label: LEVEL SELECT MENTHOL CAMPHOR ROLL ON- 10% menthol, 5% camphor roll on gel gel

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 28, 2024

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

  • OTC-ACTIVE INGREDIENTS

    Menthol 10%

    Camphor 5%

  • OTC-PURPOSE

    Topical Analgesic

  • Uses

    Temporary relief from minor aches and pains of muscles and joints, associated with strains, sprains,arthritis, backache, bruises

  • Warnings

    For external use only

  • When using this product:

    • Avoid contact with eyes, mucous membranes, and genital areas.
    • Do not use on irritated, broken, or damaged skin. If redness or irritation occurs, discontinue use
    • If skin is sensitive, consult a physician before use
    • Do not bandage the area of application
    • Do not use a heating pad with this product
    • Do not use in combination with other topical products
    • Do not expose appliation site to heat or direct sunlight
  • Stop use and ask a doctor if:

    • Condition worsens
    • Symptoms continue for more than 7 days
    • Symptoms clear up and then get worse
    • You experience blistering, severe burning pain, or swelling at applicaton site
  • If pregnant or breastfeeding:

    consult a physician before use

  • Keep out of reach of chlidren and pets

    If accidentally ingested, please seek medical help

  • Directions:

    Adults and Children 12 years and older:

    • Apply a thin layer of gel to affected area no more than 3-4 times daily
    • Allow gel to absorb before covering area
    • Wash hands, if used, after appliation with soap and water


    _______________________________________________________________

    Children under 12 years of age:

    • Consult a physician before use
  • Other Information:

    Store in a cool, dry place iwth lid closed tightly

  • Inactive Ingredients:

    Aesculus Hippocastanum (Horse Chestnut) Extract, Aloe Barbadensis (Aloe Vera) Leaf Juice, Beta-Caryophyllene, Blue #1, Caffeine, Caprylyl Glycol, Carbomer, Cymbopogon, Flexuosus (Lemongrass Oil), Glycerin, Methylsulfonylmethane (MSM), Oleth-3, Oleth-3 Phosphate, Phenoxyethanol, Polysorbate 80, Propanediol, Rosmarinus Officinalis (Rosemary) Extract, Sodium Hydroxide, Symphytum Offcinate (Comfrey) Leaf Extract, Tetrasodium Glutamate Diacetate, Tocopheryl Acetate (Vitamin E) Triethanolamine, Water, Yellow #5

  • Level Select 10% Menthol, 5% Camphor 2.5 oz Tube Roll On

    Level Select Roll On Gel 2.5 oz

  • INGREDIENTS AND APPEARANCE
    LEVEL SELECT MENTHOL CAMPHOR ROLL ON 
    10% menthol, 5% camphor roll on gel gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83191-003
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL10 g  in 100 g
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    OLETH-3 (UNII: BQZ26235UC)  
    OLETH-3 PHOSPHATE (UNII: 8Q0Z18J1VL)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    WATER (UNII: 059QF0KO0R)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CYMBOPOGON FLEXUOSUS LEAF (UNII: 7LJ4Y1UJG7)  
    CAFFEINE (UNII: 3G6A5W338E)  
    HORSE CHESTNUT (UNII: 3C18L6RJAZ)  
    ROSEMARY OIL (UNII: 8LGU7VM393)  
    DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)  
    COMFREY (UNII: D05HXK6R3G)  
    CARYOPHYLLENE (UNII: BHW853AU9H)  
    CARBOMER COPOLYMER TYPE A (UNII: 71DD5V995L)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83191-003-0370.87 g in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product02/13/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01702/13/2023
    Labeler - Kandenwood LLC (102301802)