MINTED LEAF ODORLESS PAIN RELIEF (HISTAMINE DIHYDROCHLORIDE) CREAM [MMG CONSUMER BRANDS, LLC]

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MINTED LEAF ODORLESS PAIN RELIEF (HISTAMINE DIHYDROCHLORIDE) CREAM [MMG CONSUMER BRANDS, LLC]
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NDC 73102-118-03
Set ID e9525a9c-d504-498b-9ac0-5354bd6d1241
Category HUMAN OTC DRUG LABEL
Packager MMG Consumer Brands, LLC
Generic Name
Product Class
Product Number
Application Number PART348
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  • Drug Facts

  • Active Ingredient:

    Histamine DHCl 0.03%

    Purpose

    Topical Analgesic

  • Indications:

    • For the temporary relief of minor aches and pains of the muscles and joints associated with arthritis
    • simple backache
    • sprains
    • bruises and strains.
  • Warnings:

    • For external use only.
    • Avoid contact with eyes.
    • 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 apply

    • to wounds or damaged skin.
    • Do not bandage tightly.

    If pregnant or breast feeding,

    • contact physician prior to use.
  • Directions:

    • Adults and children two-years of age or older: Apply to affected area not more than three to four times daily.
    • Children under two-years of age: consult a physcian.
  • Additional Information:

    Store at room temperature.

  • Other Ingredients:

    Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Arnica Montana Flower Extract, Boswellia Serrata Extract, Cannabis Sativa (Broad Spectrum Hemp) Oil, Caprylic/Capric Triglyceride, Cetearyl Olivate, Cetyl Alcohol, Citric Acid, Gluconolactone, Glycerin, Glyceryl Stearate, Ilex Paraguariensis (Yerba Mate’) Extract, Methylsulfonylmethane (MSM), Sodium Benzoate, Sorbitan Olivate, Xanthan Gum, Zemea (Corn) Propanediol.

  • Package Labeling:

    Label6

  • INGREDIENTS AND APPEARANCE
    MINTED LEAF ODORLESS PAIN RELIEF 
    histamine dihydrochloride cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73102-118
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HISTAMINE DIHYDROCHLORIDE (UNII: 3POA0Q644U) (HISTAMINE - UNII:820484N8I3) HISTAMINE DIHYDROCHLORIDE0.3 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    WATER (UNII: 059QF0KO0R)  
    ARCTIUM LAPPA ROOT (UNII: 597E9BI3Z3)  
    ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
    INDIAN FRANKINCENSE (UNII: 4PW41QCO2M)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    CETEARYL OLIVATE (UNII: 58B69Q84JO)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    GLUCONOLACTONE (UNII: WQ29KQ9POT)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)  
    DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SORBITAN OLIVATE (UNII: MDL271E3GR)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    CORN (UNII: 0N8672707O)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73102-118-031 in 1 BOX05/01/2019
    188 mL in 1 JAR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34805/01/2019
    Labeler - MMG Consumer Brands, LLC (117036455)
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