Label: KALAYA PAIN RELIEF 6X WITH ARNICA - PAIN RELIEF- methyl salicylate, menthol, camphor cream

  • NDC Code(s): 43493-0008-0, 43493-0008-1, 43493-0008-2
  • 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 March 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
    • do not point towards face while squeezing

    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 Control 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

  • Inactive ingredients

    water, rice bran oil, cetyl alcohol, isopropyl palmitate, sodium hydroxide, glycerin, eucalyptus oil, arnica montana, carbomer copolymer type a, ceteth-10 phosphate, dihexadecyl phosphate, dimethyl sulfone, dimethyl sulfone, diethylene glycol monophenyl ether

  • Questions or comments?

    Call toll-free 1.888.829.7165

  • Product label

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  • INGREDIENTS AND APPEARANCE
    KALAYA PAIN RELIEF 6X WITH ARNICA - PAIN RELIEF 
    methyl salicylate, menthol, camphor cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43493-0008
    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
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL4 g  in 100 g
    CAMPHOR (NATURAL) (UNII: N20HL7Q941) (CAMPHOR (NATURAL) - UNII:N20HL7Q941) CAMPHOR (NATURAL)4 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    RICE BRAN OIL (UNII: LZO6K1506A)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    ARNICA MONTANA (UNII: O80TY208ZW)  
    CARBOMER COPOLYMER TYPE A (UNII: 71DD5V995L)  
    CETETH-10 PHOSPHATE (UNII: 4E05O5N49G)  
    DIHEXADECYL PHOSPHATE (UNII: 2V6E5WN99N)  
    DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)  
    DIETHYLENE GLYCOL MONOPHENYL ETHER (UNII: LZU6ET206Z)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:43493-0008-01 in 1 BOX01/30/2023
    1119 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:43493-0008-11 in 1 BOX01/30/2023
    250 g in 1 TUBE; Type 0: Not a Combination Product
    3NDC:43493-0008-21 in 1 BOX01/30/2023
    3119 g in 1 APPLICATOR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34804/07/2021
    Labeler - Avaria Health & Beauty Corp (251366043)
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