Label: LEVEL SELECT MENTHOL CAMPHOR MUSCLE RUB- 10% menthol, 5% camphor muscle rub lotion lotion

  • 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 March 17, 2023

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  • 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 lotion to affected area no more than 3-4 times daily
    Massage product into skin until fully absorbed
    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 6 oz Tube Lotion

    Level Select 6 oz Lotion

  • INGREDIENTS AND APPEARANCE
    LEVEL SELECT MENTHOL CAMPHOR MUSCLE RUB 
    10% menthol, 5% camphor muscle rub lotion lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83191-001
    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
    CAPRYLIC/CAPRIC/LINOLEIC TRIGLYCERIDE (UNII: U73D397055)  
    ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    STARCH, TAPIOCA (UNII: 24SC3U704I)  
    TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    WATER (UNII: 059QF0KO0R)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    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)  
    VITAMIN E POLYETHYLENE GLYCOL SUCCINATE (UNII: O03S90U1F2)  
    C15-23 ALKANE (UNII: J3N6X3YK96)  
    COCO-CAPRYLATE (UNII: 4828G836N6)  
    HYDROGENATED SOYBEAN OIL (UNII: A2M91M918C)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83191-001-0170.87 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 not finalpart34802/13/2023
    Labeler - Kandenwood LLC (102301802)
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