Label: DR MANALI HAIR SERUM FOR MEN- minoxidil 5% liquid

  • NDC Code(s): 83361-002-01, 83361-002-02
  • Packager: Dr Manali Products
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated January 19, 2024

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

  • ACTIVE INGREDIENT

    Active ingridient : minoxidil USP 5%

  • PURPOSE

    Hair Growth

  • INDICATIONS & USAGE

    Uses: to regrow hair on the top of the scalp

  • WARNINGS

    Warnings: For eldemal use only. For use by men only. Flarnmabk!: Keep away from fire or flame

    Warnings: Do not use 11:■You are a woman ■ You have no family histcxy of hair loss ■ Your hair loss is sudden or patchy ■ You do not know the reason for your hair loss ■You do not know the reason for your hair loss you are under 18 years of age.■ Do not use on babies or children ■Your scalp is red, inflamed, infected, irritated, or painful ■ You use other medications on the scalp

    Ask a doctor before use if you have heart disease.

  • WHEN USING

    When using this product: ■ Do not apply on other areas of the body ■ Avoid contact with eyes. In case of contact rinse eyes wnh large announts of cool tap water ■ It takes time to regrow hair. Results may occur at 2 months 􀁒h twice daily usage. For some men you may need to use this product for at least

    4 months before you see results ■The annount of hair regrowth is different for each person. This product will not work for all men.

  • DO NOT USE

    Do not use if :■You are a woman ■ You have no family history of hair loss ■ Your hair loss is sudden or patchy ■ You do not know the reason for your hair loss ■You do not know the reason for your hair loss you are under 18 years of age.■ Do not use on babies or children ■Your scalp is red, inflamed, infected, irritated, or painful ■ You use other medications on the scalp

  • ASK DOCTOR

    Ask a doctor before use if you have heart disease.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222)

  • DOSAGE & ADMINISTRATION

    Apply 1 ml with dropper 2 times a day directly onto scalp in the area of hair loss ■ Using more or more often will not improve results ■ Continued use is necessary to increase and keep your hair ■ Regrowth, or hair loss will begin again

  • STORAGE AND HANDLING

    Store at room temperature 68 to 77 F (or 20 to 25 C), in a dry place. Keep tightly closed..

  • INACTIVE INGREDIENT

    Inactive Ingredients: Biotin Liposomes (water, alcohol, panthenol, lecithin, tocopheryl acetate, caffeine, biotin), Ethyl Alcohol, Dimethyl lsosorbide, Melatonin, Prickly Pear Extract (glycerin & water & Opuntia Tuna Flower/Stem Extract), Propylene Glycol, Red Clover Extract (Certified Organic Red Clover (Trifolium Pratense) dried Leal, vegetable glycerin, alcohol, water], Saw Palmetto/Serenoa repens Extract (glycerin, water, Serenoa Serrulata Fruit Extract, Maltodextrin), Vitamin A Liposomes (lecithin, retinal, polysorbate 20)

  • QUESTIONS

    Questions and Comments? Call1 30111116 8333

    Monday through Friday 9:00 AM -4:00 PM EST

    Email us at info@drmanaliproducts.com

  • PRINCIPAL DISPLAY PANEL

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  • INGREDIENTS AND APPEARANCE
    DR MANALI HAIR SERUM FOR MEN 
    minoxidil 5% liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83361-002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MINOXIDIL (UNII: 5965120SH1) (MINOXIDIL - UNII:5965120SH1) MINOXIDIL5 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    MELATONIN (UNII: JL5DK93RCL)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    ALCOHOL (UNII: 3K9958V90M)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)  
    BIOTIN (UNII: 6SO6U10H04)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    VITAMIN A (UNII: 81G40H8B0T)  
    PRICKLY PEAR FRUIT (UNII: 18V8PAQ629)  
    RED CLOVER (UNII: L9153EKV2Y)  
    TRIFOLIUM PRATENSE LEAF (UNII: 612YOZ36DG)  
    WATER (UNII: 059QF0KO0R)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SAW PALMETTO (UNII: J7WWH9M8QS)  
    CAFFEINE (UNII: 3G6A5W338E)  
    OPUNTIA TUNA STEM (UNII: 2HCC68I98K)  
    DIMETHYL ISOSORBIDE (UNII: SA6A6V432S)  
    RETINOL (UNII: G2SH0XKK91)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83361-002-021 in 1 CARTON02/01/2024
    1NDC:83361-002-0160 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM03202/01/2024
    Labeler - Dr Manali Products (110035406)
    Establishment
    NameAddressID/FEIBusiness Operations
    Dr Manali Products110035406manufacture(83361-002)