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%

    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 damaged 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 affected 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, Helianthus Annuus (Sunflower) Oil, Mentha Viridis (Spearmint) Oil, Mineral Oil, Parfum (Fragrance), PEG-100 Stearate, Phenoxyethanol, SD-Alcohol 40B, Triethanolamine, Xanthan Gum.

  • Package Labeling:

    Label4

  • INGREDIENTS AND APPEARANCE
    ALO THERAPEUTIC MASSAGE 
    menthol, histamine dihydrochloride cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71061-766
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL30 mg  in 1 mL
    HISTAMINE DIHYDROCHLORIDE (UNII: 3POA0Q644U) (HISTAMINE - UNII:820484N8I3) HISTAMINE DIHYDROCHLORIDE1 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    TROLAMINE (UNII: 9O3K93S3TK)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    WATER (UNII: 059QF0KO0R)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    SPEARMINT OIL (UNII: C3M81465G5)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71061-766-055 mL in 1 BOTTLE; Type 0: Not a Combination Product11/10/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01711/10/2016
    Labeler - CMI Therapy Solutions (080327444)