GROMEDI 5X (MINOXIDIL 5%) SPRAY [ORANGE LAB]

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GROMEDI 5X (MINOXIDIL 5%) SPRAY [ORANGE LAB]
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NDC 71331-104-04
Set ID 741edbef-828c-7a86-e053-2a91aa0a76fb
Category HUMAN OTC DRUG LABEL
Packager Orange Lab
Generic Name
Product Class Arteriolar Vasodilator
Product Number
Application Number
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  • Active Ingredient

    Active ingredient

  • Ask a doctor

    Ask a doc

  • DO NOT USE IF

    Do not use if

  • Maybe be harmful if used when pregnant or breast-feeding.

    Pregnant or breast feeding

  • When using this product

    when using this product

  • Inactive ingredient

    Inactive Ingredient

  • Directions

    Directions

  • Do not use on children

    do not use on children

  • Directions for dosage / frequency

    dosage

  • Dosage and Administration

    dosage

  • Warnings section

    warnings

  • Indications and usage

    indication

  • Keep out of reach of children

    Keep out of reach of children

  • Purpose

    purpose

  • Front display panel

    front panel image

  • INGREDIENTS AND APPEARANCE
    GROMEDI 5X 
    minoxidil 5% spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71331-104
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MINOXIDIL (UNII: 5965120SH1) (MINOXIDIL - UNII:5965120SH1) MINOXIDIL5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    APIGENIN (UNII: 7V515PI7F6)  
    BIOTINOYL TRIPEPTIDE-1 (UNII: O6380721VA)  
    SAW PALMETTO (UNII: J7WWH9M8QS)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    OLEANOLIC ACID (UNII: 6SMK8R7TGJ)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    URTICA DIOICA ROOT (UNII: J8HE8A6E5T)  
    PPG-26-BUTETH-26 (UNII: 2II1K6TZ4P)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    BIOTIN (UNII: 6SO6U10H04)  
    CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    BEE PROPOLIS EXTRACT (UNII: 6Y8XYV2NOF)  
    PAULLINIA CUPANA SEED (UNII: C21GE7524R)  
    ASIAN GINSENG (UNII: CUQ3A77YXI)  
    MENTHOL (UNII: L7T10EIP3A)  
    CETRIMONIUM BROMIDE (UNII: L64N7M9BWR)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
    DEHYDROACETIC ACID (UNII: 2KAG279R6R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71331-104-04118 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product08/23/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other08/22/2018
    Labeler - Orange Lab (004862271)
    Registrant - Orange Lab (004862271)
    Establishment
    NameAddressID/FEIBusiness Operations
    Orange Lab004862271manufacture(71331-104)
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