Label: ALO THERAPEUTIC MASSAGE PAIN RELIEVING - menthol and histamine dihydrochloride cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 03/13

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

  • ALO THERAPEUTIC MASSAGE CREAM PAIN RELIEVING
  • Active ingredients

    Menthol 3.00%
    Histamine Dihydrochloride 0.100%

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  • Purpose

    External Analgesic

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  • Uses

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

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  • 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.

    • If pregnant or breast feeding,

    contact physician prior to use.

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  • Directions

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

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  • Distributed by:

    THERAPLEX SOLUTIONS
    P.O. BOX 770125
    MIAMI, FL 33177
    Questions? Call 305.609.4229
    www.alopainrelief.com

    THIS PRODUCT IS NOT TESTED ON ANIMALS.

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  • 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 CIRCULATIONS TO SPEED HEALING

    32 f l o z
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  • ALO THERAPEUTIC MASSAGE CREAM PAIN RELIEVING 32oz (51457-001-32)
  • INGREDIENTS AND APPEARANCE
    ALO THERAPEUTIC MASSAGE PAIN RELIEVING 
    menthol, histamine dihydrochloride cream
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:51457-001
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    MENTHOL (MENTHOL) MENTHOL 3.00 g  in 100 g
    HISTAMINE DIHYDROCHLORIDE (HISTAMINE) HISTAMINE DIHYDROCHLORIDE 0.100 g  in 100 g
    Inactive Ingredients
    Ingredient Name Strength
    WATER  
    BUTYLENE GLYCOL  
    CETYL ALCOHOL  
    ETHYLHEXYLGLYCERIN  
    DIMETHYL SULFONE  
    GLYCERYL MONOSTEARATE  
    MINERAL OIL  
    PEG-100 STEARATE  
    PHENOXYETHANOL  
    TROLAMINE  
    XANTHAN GUM  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:51457-001-32 1 in 1 PACKAGE
    1 907.18474 g in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part348 03/20/2013
    Labeler - Theraplex Solutions (078500057)
    Establishment
    Name Address ID/FEI Business Operations
    Pure Source Inc. 969241041 manufacture(51457-001)
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