Label: CALYPXO HP PAIN RELIEF- methyl salicylate, menthol cream

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

Drug Label Information

Updated October 16, 2023

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  • SPL UNCLASSIFIED SECTION

    Drugs Facts

  • Active Ingredients

    Methyl Salicylate………15.00%

    Menthol……………………10.00%

  • 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.
    • use with heating pad.
    • 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, Ethylhexylglycerin, Isopropyl Myristate, PEG-8, Phenoxyethanol, Sodium Lauryl Sulfate, Triethanolamine.

  • Principal Display Panel

    NDC 76420-999-01

    Calypxo HP

    Pain Relief Cream

    4 oz (113g)

    Distributed by:
    Enovachem
    PHARMACEUTICALS
    Torrance, CA 90501
    (310) 320-0100

    image description

  • INGREDIENTS AND APPEARANCE
    CALYPXO HP PAIN RELIEF 
    methyl salicylate, menthol cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76420-999
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE15 g  in 100 g
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL10 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)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76420-999-01113 g in 1 BOTTLE; Type 0: Not a Combination Product12/10/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01712/10/2020
    Labeler - Asclemed USA, Inc (059888437)
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