Label: BIOTIN- oil oil

  • NDC Code(s): 83872-455-01
  • Packager: Shenzhen Xiaomai Manufacturing Co., Ltd.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated August 29, 2024

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

  • Active Ingredient

    Biotin 50%

  • Purpose

    Hair Regrowth Treatment

  • Use

    Use to regrow hair on the top of the scalp

  • Warnings

    -For external use only
    -Keep away from fire and flame

  • Do not use

    -You have no family history of hair loss,hair loss is sudden and/or patchy.
    -You do not know the reason for your hair loss.
    -You are under 18 years of age.Do not use it on bables and children your scalp is red.inflamed,infected,imitated,or painful.
    -You use other medicines on the scalp
    -Ask a Doctor before use of you have Heart disease.

  • When Using

    Do not apply to other parts of the body.void contact with eyes.In case of accidental contact,rinse eyes with a large amount of cool tap water.
    It takes time to regrow hair.You may need to use this product 2 times a day for a least 4 months before you see results,The amount of hair regrowth is different for each person.

  • Stop Use

    chest pain, rapid heart beat.faintness, or dizziness occurs sudden, unexplained weight gain occurs.
    your hands or feet swell scalp imitation or redness occurs
    May be harmful if used when pregnant or breast-feeding
    Keep Out Of Reach Of Chlidren:
    if swallowed,get medical help or
    contact a Poison Control Center right away.

  • Ask Doctor

    When Pregnant or breast-feeding.

  • Keep Out Of Reach Of Chlidren

    Keep Out Of Reach Of Chlidren

  • Directions

    1. Apply 1 ML(few drops) directly onto scalpon the hairloss area.
    2. Use fingertips to massage solution intoskin/hair for2-3 minutes.
    3. Allow time for hair to fully absorb GrowthOil For bestresults, use twice daily onclean dry hair.

  • Other information

    Before use, read all information on thecarton Store at controlled room temperature20 to 25 C (68 to 77°F)

  • Inactive ingredients

    BiotinHelianthus Annuus (Sunfower) Seed OilAloe Barbadensis Leaf ExtractRosmarinus Officinalis (Rosemary) Leaf ExtractHamamelis Virginiana (Witch Hazel) Leaf ExtractMentha Piperita (Peppermint) Leaf ExtractRosmarinus Officinalis (Rosemary) Leaf OilCastor Oil Propanediol Esters

  • PRINCIPAL DISPLAY PANEL

    LBEAL

  • INGREDIENTS AND APPEARANCE
    BIOTIN 
    oil oil
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83872-455
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BIOTIN (UNII: 6SO6U10H04) (BIOTIN - UNII:6SO6U10H04) BIOTIN15 g  in 30 mL
    Inactive Ingredients
    Ingredient NameStrength
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    HELIANTHUS ANNUUS POLLEN (UNII: 28D6K7E9IP)  
    CASTOR OIL (UNII: D5340Y2I9G)  
    ROSEMARY OIL (UNII: 8LGU7VM393)  
    WITCH HAZEL (UNII: 101I4J0U34)  
    ROSMARINUS OFFICINALIS FLOWERING TOP OIL (UNII: OXN0D3N28L)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83872-455-0130 mL in 1 BOTTLE, UNIT-DOSE; Type 0: Not a Combination Product08/30/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph Drug505G(a)(3)08/30/2024
    Labeler - Shenzhen Xiaomai Manufacturing Co., Ltd. (712999147)
    Establishment
    NameAddressID/FEIBusiness Operations
    Shenzhen Xiaomai Manufacturing Co., Ltd.712999147manufacture(83872-455)