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

  • 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 December 9, 2020

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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 not finalpart34812/10/2020
    Labeler - Asclemed USA, Inc (059888437)
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