Label: KALAYA BACK AND NECK PAIN RELIEF- methyl salicylate, menthol, camphor liquid

  • NDC Code(s): 43493-0009-0
  • Packager: Avaria Health & Beauty Corp
  • 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 February 16, 2023

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  • Drug Facts

  • Active ingredients

    Camphor 11%
    Menthol 16%
    Methyl salicylate 25%

  • Purpose

    Topical Analgesic

  • Uses

    Provides penetrating pain relief for the temporary relief of minor aches and pains of muscles and joints

  • Warnings

    For External Use Only. Flammable. Keep away from heat or flame.


    Do not use:
    • on wounds or damaged skin
    • with a heating pad
    • on a child under 12 years of age with arthritis-like conditions

    When using this product avoid contact with eyes or mucous membranes, do not bandage tightly.


    Stop use and ask a doctor if condition worsen or symptoms persist more than 7 days, symptoms clear up and occur again within a few days and/or excessive skin irritation occurs.


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

  • KEEP OUT OF REACH OF CHILDREN

  • Directions

    Adults and children 12 years and over: Spray evenly onto affected areas no more than 3 to 4 times daily. Apply spray to affected areas and

    allowed to dry or thoroughly massage until penetrated. Wash hands with soap and water after use.

  • Other information

    • Store at 59°F - 77°F

  • Inactive ingredients

    Alcohol Denat., Cannabis Sativa Seed Oil, Citric Acid, Mentha Piperita (Peppermint) Oil

  • Questions or comments?

    Call toll-free 1.888.829.7165

  • Product label

    image description

  • INGREDIENTS AND APPEARANCE
    KALAYA BACK AND NECK PAIN RELIEF 
    methyl salicylate, menthol, camphor liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43493-0009
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE25 g  in 100 mL
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL16 g  in 100 mL
    CAMPHOR (NATURAL) (UNII: N20HL7Q941) (CAMPHOR (NATURAL) - UNII:N20HL7Q941) CAMPHOR (NATURAL)11 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:43493-0009-01 in 1 BOX02/16/2023
    160 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34802/16/2023
    Labeler - Avaria Health & Beauty Corp (251366043)
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