Label: KALAYA EXTRA STRENGTH PAIN RELIEF GEL WITH ARNICA- methyl salicylate, menthol, camphor gel

  • NDC Code(s): 43493-0012-0
  • Packager: Avaria Health & Beauty Corp
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 21, 2023

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  • Drug Facts

  • Active ingredients

    Camphor 4%
    Menthol 4%
    Methyl salicylate 11%

  • Purpose

    Topical Analgesic

  • Uses

    Penetrating pain relief for the temporary relief of minor aches and pains of muscle and joint pain associated with arthritis, backache, strains, sprains and bruises.

  • Warnings

    For external use only


    Do not use

    • on wounds or damaged skin
    • with a heating pad
    • on children 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

    • condition worsen or symptoms persist for more than 7 days
    • symptoms clear up and occur again within a few days
    • excessive skin irritation occurs

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Cntrol Center right away. 

  • KEEP OUT OF REACH OF CHILDREN

  • Directions

    Adults and children 12 years and over. Use no more than 3-4 times daily. Apply cream to affected areas and thoroughly massage until penetrated. Wash hands with soap and water after use.

  • Other information

    • Store at 59°F - 77°F

    • If seal is broken, do not use

  • Inactive ingredients

    Alcohol Denat., Aminomethyl propanol, Arnica Montana Flower Extract, Carbopol Ultrez 10, Cetearyl Alcohol, Ethylhexylglycerin, Phenoxyethanol, Glycerin, Polysorbate 80, Water

  • Questions or comments?

    Call toll-free 1.888.829.7165

  • Product label

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  • INGREDIENTS AND APPEARANCE
    KALAYA EXTRA STRENGTH PAIN RELIEF GEL WITH ARNICA 
    methyl salicylate, menthol, camphor gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43493-0012
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE11 g  in 100 g
    LEVOMENTHOL (UNII: BZ1R15MTK7) (LEVOMENTHOL - UNII:BZ1R15MTK7) LEVOMENTHOL4 g  in 100 g
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)4 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
    CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:43493-0012-01 in 1 CARTON12/01/2023
    1100 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01702/16/2023
    Labeler - Avaria Health & Beauty Corp (251366043)
    Establishment
    NameAddressID/FEIBusiness Operations
    Avaria Health & Beauty Corp251366043manufacture(43493-0012)
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