Label: DR. FREDS MIRACLE RUB- histamine dihydrochloride cream

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

Drug Label Information

Updated December 14, 2024

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

View All Sections
  • 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 CARTON02/09/201701/01/2023
    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 DrugM01706/06/201301/01/2023
    Labeler - Pure Source, LLC (080354456)
    Establishment
    NameAddressID/FEIBusiness Operations
    Pure Source, LLC080354456manufacture(65121-403)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!