Label: ALO THERAPEUTIC MASSAGE- menthol, histamine dihydrochloride cream

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

Drug Label Information

Updated November 10, 2023

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  • Drug Facts


  • Active Ingredients

    Menthol                                   3.00%

    Histamine Dihydrochloride    0.100%  

  • Purpose

    External Analgesic

  • Uses

    For temporary relief of minor aches and pains associated with backache, arthritis, bruises and sprains.

  • Warnings

    • For external use only.
    • Avoid contact with eyes.
    • Do not apply to open wounds or damages skin.
    • If symptoms persist for more than seven days, discontinue use and consult physician.
  • Keep out of reach of children.

    If swallowed, consult physician.  Do not bandage tightly.

  • If pregnant or breast feeding,

    contact physician prior to use.

  • Directions

    • Apply directly to effected area.
    • Do not use more than four times per day.
  • Other Ingredients

    Aqua (Deionized Water), Butylene Glycol, Carbomer, Cetyl Alcohol, Ethylhexylglycerin, Dimethyl Sulfone(MSM), Glyceryl Stearate, Healianthus Annuus (Sunflower) Oil, Mentha Viridis (Spearmint) Oil, Mineral Oil, Parfum (Fragrance), PEG-100 Stearate, Phenoxyethanol, SD-Alcohol 40B, Triethanolamine, Xanthan Gum.

  • Distributed by:

    THERAPLEX SOLUTIONS

    Miami, Florida 33298  

    Questions?  call 305.609.4229

    www.alo-21.com

  • PRINCIPAL DISPLAY PANEL

    Alo THERAPEUTIC MASSAGE CREAM; PAIN RELIEVING; DEEP PENETRATING, PAIN RELIEF FROM ARTHRITIS; SORE MUSCLES AND JOINTS; BACK PAIN;BRUISES AND SPRAINS STIMULATES CIRCULATION TO SPEED HEALING 4 fl oz Drug Facts

  • Alo Therapeutic Massage Cream 4oz/118g (51457-000-04)

    Alo 1Alo 2

  • INGREDIENTS AND APPEARANCE
    ALO THERAPEUTIC MASSAGE 
    menthol, histamine dihydrochloride cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51457-000
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL3 g  in 100 g
    HISTAMINE DIHYDROCHLORIDE (UNII: 3POA0Q644U) (HISTAMINE - UNII:820484N8I3) HISTAMINE DIHYDROCHLORIDE0.1 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    XANTHAN GUM (UNII: TTV12P4NEE)  
    WATER (UNII: 059QF0KO0R)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    SPEARMINT OIL (UNII: C3M81465G5)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51457-000-04118 g in 1 TUBE; Type 0: Not a Combination Product02/03/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01706/07/2012
    Labeler - Theraplex Solutions (078500057)
    Establishment
    NameAddressID/FEIBusiness Operations
    Pure Source, LLC080354456manufacture(51457-000)
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