Label: DR. FREDS MIRACLE RUB- histamine dihydrochloride cream

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

Drug Label Information

Updated November 5, 2023

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  • Dr. Fred's MIRACLE RUB


  • Active Ingredients:

    Histamine Dihydrochloride 0.025%

  • Purpose

    External Analgesic

  • Uses:

    For temporary relief of minor aches and pains associated with simple 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 use

    if you have a known allergy to any of the ingredients listed. - 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:

    Aloe Barbadensis Leaf (Aloe Vera Juice) Gel, Aqua (Deionized Water), Arnica Montana Extract, Carbomer, C13-14 Isoparaffin, Cetearyl Olivate, Dimethyl Sulfone (MSM), Laureth-7, Magnesium Sulfate, Parfum (Fragrance), Polyacrylamide, Potassium Sorbate, Royal Jelly, Sodium Benzoate, Sodium Stearate, Sorbitan Olivate, Stearic Acid, Triethanolamine.

  • Manufactured for:

    Haleivo, Inc. Ojai, Ca 93023 USA www.DrFredsMeds.com


  • PRINCIPAL DISPLAY PANEL

    KNOCK OUT PAIN WITH Dr. Fred's MIRACLE RUB  OJAI ORIGINAL PATENT PENDING


    4 FL. OZ. (118 ML)

  • Dr. Fred's MIRACLE RUB 4oz/118ml (65121-403-25)

    Label

  • INGREDIENTS AND APPEARANCE
    DR. FREDS MIRACLE RUB 
    histamine dihydrochloride cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65121-403
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HISTAMINE DIHYDROCHLORIDE (UNII: 3POA0Q644U) (HISTAMINE - UNII:820484N8I3) HISTAMINE DIHYDROCHLORIDE0.25 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    WATER (UNII: 059QF0KO0R)  
    ARNICA MONTANA (UNII: O80TY208ZW)  
    C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
    CETEARYL OLIVATE (UNII: 58B69Q84JO)  
    DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)  
    LAURETH-7 (UNII: Z95S6G8201)  
    MAGNESIUM SULFATE, UNSPECIFIED (UNII: DE08037SAB)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    ROYAL JELLY (UNII: L497I37F0C)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM STEARATE (UNII: QU7E2XA9TG)  
    SORBITAN OLIVATE (UNII: MDL271E3GR)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65121-403-251 in 1 CARTON02/09/2017
    1118 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01706/06/2013
    Labeler - Pure Source, LLC (080354456)
    Establishment
    NameAddressID/FEIBusiness Operations
    Pure Source, LLC080354456manufacture(65121-403)
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