Label: KASEHA PAIN RELIEVING GEL- camphor, capsaicin, menthol, methyl salicylate gel

  • NDC Code(s): 83056-002-02
  • Packager: Denali Natural Products
  • 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 15, 2023

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  • Drug Facts

  • Active ingredients

    camphor 3.5%

    capsaicin 0.18%

    menthol 1.25%

    methyl salicylate 12%

  • Purpose

    pain relieving gel

  • Use

    For the temporary relief of minor aches and pains of muscles and joints

  • Warnings

    For external use only.

    Do not use otherwise than as directed.

    When using this product • avoid contact with the eyes and mucous membranes

    • do not apply to wounds or damaged skin • do not bandage tightly

    Stop use and ask a doctor if condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days. Discontinue use if excessive irritation of the skin develops

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

  • Directions

    • Adults and children 3 years of age and older: Apply to the affected area not more than 3 to 4 times daily. • Children under 3 years of age: Consult a doctor.
  • Inactive ingredients

    Aloe vera extract, carbomer 940, eucalyptus globulus leaf essential oil, glycerin, guaiacum, paullinia cupana fruit powder, phenoxyethanol, rosmarinus officinalis (rosemary) leaf oil, rosmarinus officinalis (rosemary) leaf powder, sodium acrylate/sodium acryloyldimethyltaurate copolymer (4000000 MW), triethanolamine, water.

  • SPL UNCLASSIFIED SECTION

    KASEHA

    Pain Relieving Gel

    2 fl oz (60mL)

    DISTRIBUTED BY:

    DENALI NATURAL PRODUCTS,

    1411 N. BATAVIA ST STE 116

    ORANGE, CA 92867

    MADE IN MEXICO

    TEL. 562-390-2873

  • PRINCIPAL DISPLAY PANEL

    label 1

    label 2

    label 3

    label 4

  • INGREDIENTS AND APPEARANCE
    KASEHA PAIN RELIEVING GEL 
    camphor, capsaicin, menthol, methyl salicylate gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83056-002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL1.25 g  in 100 mL
    CAMPHOR (NATURAL) (UNII: N20HL7Q941) (CAMPHOR (NATURAL) - UNII:N20HL7Q941) CAMPHOR (NATURAL)3.5 g  in 100 mL
    CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN0.18 g  in 100 mL
    METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE12 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ROSEMARY (UNII: IJ67X351P9)  
    GUARANA (UNII: 52U584F1CA)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER (4000000 MW) (UNII: 1DXE3F3OZX)  
    CARBOMER 940 (UNII: 4Q93RCW27E)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GUAIACUM OFFICINALE WOOD (UNII: 51EUI60BAN)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    GUAIACUM OFFICINALE WOOD OIL (UNII: D1S7X78492)  
    ROSEMARY OIL (UNII: 8LGU7VM393)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83056-002-0260 mL in 1 JAR; Type 0: Not a Combination Product04/07/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34804/07/2023
    Labeler - Denali Natural Products (118803692)
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