Label: CALYPXO PAIN RELIEF- methyl salicylate, menthol cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 1, 2023

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  • SPL UNCLASSIFIED SECTION

    Drugs Facts

  • Active Ingredients

    Methyl Salicylate………10.00%

    Menthol…………………3.00%

  • Purpose

    Topical Analgesic

    Topical Analgesic

  • Uses

    For temporary relief of minor aches and pains associated with simple backaches, arthritis, bruises, sprains and cramps.

  • Warning

    For external use only.

    Avoid contact with eyes and mucous membranes.

    Do not bandage tightly or cover treated areas.

    Do not use with heating pad.

    Do not apply to open wounds or damages skin.

    A mild burning sensation may occur. If severe burning sensation occurs, discontinue use immediately.

    If symptoms persist for more than seven days, discontinue use and consult physician.

    Keep out of reach of children.If swallowed, consult physician.

    If pregnant or breast feeding, contact physician prior to use.

  • Directions

    For adults apply directly to affected area. Repeat as necessary, but do not use more than 3-4 times daily.

  • Additional Information

    Store at room temperature.

  • Other Ingredients

    Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Cetyl Alcohol, Diazolidinyl Urea, Isopropyl Myristate, Methyl Paraben, PEG-8, Propyl Paraben, Propylene Glycol, Sodium lauryl Sulfate, Triethanolamine.

  • Principal Display Panel

    Calypxo Cream 1

  • INGREDIENTS AND APPEARANCE
    CALYPXO PAIN RELIEF 
    methyl salicylate, menthol cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80425-0369(NDC:76420-450)
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE10 g  in 100 g
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL3 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    WATER (UNII: 059QF0KO0R)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:80425-0369-1113 g in 1 BOTTLE; Type 0: Not a Combination Product12/01/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01712/01/2023
    Labeler - Advanced Rx Pharmacy of Tennessee, LLC (117023142)
    Establishment
    NameAddressID/FEIBusiness Operations
    Advanced Rx Pharmacy of Tennessee, LLC117023142repack(80425-0369)
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