Label: CALYPXO 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 June 19, 2017

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

    Drugs Facts

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  • Active Ingredients

    Methyl Salicylate……….10.00%

    Menthol…………………...3.00%

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  • Purpose

    Topical Analgesic

    Topical Analgesic

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  • Uses

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

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  • 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.

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  • Directions

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

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  • 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.

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  • Principal Display Panel

    Calypxo

    Pain Relief Cream

    4 oz (113g)

    Distributed by:

    Enovachem

    PHARMACEUTICALS

    Torrance, CA 90501

    (310) 320-0100

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  • INGREDIENTS AND APPEARANCE
    CALYPXO PAIN RELIEF 
    methyl salicylate, menthol cream
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:76420-450
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Methyl Salicylate (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) Methyl Salicylate 10 g  in 100 g
    Menthol (UNII: L7T10EIP3A) (Menthol - UNII:L7T10EIP3A) Menthol 3 g  in 100 g
    Inactive Ingredients
    Ingredient Name Strength
    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 Code Package Description Marketing Start Date Marketing End Date
    1 NDC:76420-450-12 113 g in 1 BOTTLE; Type 0: Not a Combination Product 01/15/2014
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part348 01/15/2014
    Labeler - Asclemed USA, Inc (059888437)
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