Label: HAIR STRENGTHENS OIL oil

  • NDC Code(s): 83604-101-01
  • Packager: Shenzhen Xiyue Electronic Commerce Co., Ltd.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated August 21, 2023

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  • SPL UNCLASSIFIED SECTION

    HAIR STRENGTHENS OIL

  • ACTIVE INGREDIENT

    BIOTIN 5%
    PANAX GINSENG ROOT EXTRACT 2%
    ZINGIBER OFFICINALE (GINGER) ROOT EXTRACT 2%
    ORIENTAL ARBORVITAE LEAFYTWIGS EXTRACT 0.5%
    PINUS PALUSTRIS EXTRACT 0.4%

  • PURPOSE

    Strengthens Hair

    Promote Hair Longer

    Fuller Healthier Hair

  • INDICATIONS & USAGE

    Strengthens Hair

    Promote Hair Longer
    Fuller Healthier Hair

  • WARNINGS

    For externaluse only.
    Keep out of reach of children.

    For externaluse only.
    Keep out of reach of children.
    Avoid eyes, lips. (lfthe productaccidentally touches the eyes, pleaserinse it with water immediately. )

  • DO NOT USE

    TIPS: we recommend do patch testbefore use.

    Avoid eyes, lips. (lfthe productaccidentally touches the eyes, pleaserinse it with water immediately.)

  • WHEN USING

    For externaluse only.
    Keep out of reach of children.
    Avoid eyes, lips. (lfthe productaccidentally touches the eyes, pleaserinse it with water immediately. )

  • STOP USE

    If discomfort occurs, immediately stop using and seek medical advice

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • DOSAGE & ADMINISTRATION

    1. Forthe best results, apply to slightlydamp hair after washing or rinsing
    2. Apply 4-6 drops of oil to the scalp andgently massage with fingers from theroot to the tip ofthe hair untilthe hairstrengthens oilis absorbed
    3. Apply the hair strengthens oil 2 - 4times a week

  • STORAGE AND HANDLING

    Store in a cooland dry place

  • INACTIVE INGREDIENT

    WATER
    GLYCERIN
    GLYCINE
    HYDROGENATED CASTOR OIL
    PEPPERMINT OIL
    CAFFEINE
    DIMETHYL ISOSORBIDE
    MAGNOLIA BIONDII EXTRACT
    AVENA SATIVA EXTRACT
    SODIUM HYALURONATE

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    HAIR STRENGTHENS OIL 
    hair strengthens oil oil
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83604-101
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN0.05 mg  in 100 mL
    AMENTOFLAVONE (UNII: 9I1VC79L77) (AMENTOFLAVONE - UNII:9I1VC79L77) AMENTOFLAVONE0.5 mg  in 100 mL
    BIOTIN (UNII: 6SO6U10H04) (BIOTIN - UNII:6SO6U10H04) BIOTIN5 mg  in 100 mL
    ASIAN GINSENG (UNII: CUQ3A77YXI) (ASIAN GINSENG - UNII:CUQ3A77YXI) ASIAN GINSENG2 mg  in 100 mL
    PINUS PALUSTRIS LEAF (UNII: OT6R5143A1) (PINUS PALUSTRIS LEAF - UNII:OT6R5143A1) PINUS PALUSTRIS LEAF0.4 mg  in 100 mL
    GINGER (UNII: C5529G5JPQ) (GINGER - UNII:C5529G5JPQ) GINGER2 mg  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    DIMETHYL ISOSORBIDE (UNII: SA6A6V432S)  
    HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    MEDIORESINOL DIMETHYL ETHER (UNII: 95DA2NWV8P)  
    OAT (UNII: Z6J799EAJK)  
    WATER (UNII: 059QF0KO0R)  
    GLYCINE (UNII: TE7660XO1C)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    CAFFEINE (UNII: 3G6A5W338E)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83604-101-0130 mL in 1 BOTTLE; Type 0: Not a Combination Product07/26/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33407/26/2023
    Labeler - Shenzhen Xiyue Electronic Commerce Co., Ltd. (419273105)
    Registrant - Shenzhen Xiyue Electronic Commerce Co., Ltd. (419273105)
    Establishment
    NameAddressID/FEIBusiness Operations
    Shenzhen Xiyue Electronic Commerce Co., Ltd.419273105manufacture(83604-101)
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