Label: SOTI HAIR GROWTH SERUM- minoxidil liquid

  • NDC Code(s): 81653-013-01
  • Packager: Guangzhou Jianyuan Biological Technology Co., Ltd.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated December 28, 2023

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

  • Active ingredient

    Minoxidil 5% w/v

  • Use

    to regrow hair on the top of the scalp (vertex only, see pictures on side of carton)

  • Purpose

    Hair Growth Serum for people

  • Warnings

    For external use only
    Flammable:
    Keep away from fire or flame

    Do not use if

    ■ our amount of hair loss is different than that shown the side of this carton or your hair loss is on the front of the scalp. Hair Growth Serum is not intended for frontal baldness or receding hairline

    ■ you have no family history of hair loss

    ■ your hair loss is sudden and/or patch

    ■ you do not know the reason for your hair loss

    ■ you are under 18 years of age. Do not use on babies and children

    ■ your scalp is red, inflamed, infected, irritated, or painful

    ■ you use other medicines on the scalp

    Ask a doctor before use if you have

    heart disease

    When using this product

    ■ do not apply on other parts of the body

    ■ avoid contact with the eyes. In case of accidental contact, rinse eyes with large amounts of cool tap water

    ■ some people have experienced changes in hair color and or texture

    ■ it takes time to regrow hair. Results may occur at 2 months with twice a day usage. For some people, you may need to use this product for at least 4 months before you see results.

    ■ the amount of hair regrowth is different for each person. This product will not work for all people

    Stop use and ask a doctor if

    ■ chest pain, rapid heartbeat, faintness, or dizziness occurs

    ■ sudden, unexplained weight gain occurs

    ■ your hands or feet swell

    ■ scalp irritation or redness occurs

    ■ unwanted facial hair growth occurs

    ■ you do not see hair regrowth in 4 months

    May be harmful if used when pregnant or breast-feeding

    Keep out of reach of children.

    if swallowed, get medical help or contact a Poison Control Center right away.

  • Other information

    keep the carton. t contains important information.
    store at 20° to 25°C (68°to 77°F). Keep tightly closed.

  • Directions

    ■ Apply 1 ml twice a day directly onto the scalp in the hair loss area

    ■ massage into scalp with fingers, then wash hands well

    ■ 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

  • Ingredients

    Reynoutria Multiflora Whole

    Angelica Sinensis Whole

    Biotin

    Platycladus Orientalis Leaf

    Asian Ginseng

    Carthamus Tinctorius Whole

    Dictamnus Dasycarpus Root Bark

    Ligustrum Lucidum Fruit

    Alcohol

    Ligusticum Sinense Subsp. Chuanxiong Root

    Glycyrrhiza Uralensis Whole

    Capsaicin

    MARINE COLLAGEN SOLUBLE

    Ginger

    Arctium Lappa Whole

  • Label

    60

  • INGREDIENTS AND APPEARANCE
    SOTI HAIR GROWTH SERUM 
    minoxidil liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81653-013
    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
    ANGELICA SINENSIS WHOLE (UNII: 697D19QDBN)  
    PLATYCLADUS ORIENTALIS LEAF (UNII: 32E5V7G32B)  
    LIGUSTRUM LUCIDUM FRUIT (UNII: M9G2U96DUT)  
    GLYCYRRHIZA URALENSIS WHOLE (UNII: 8XW1DS8UIR)  
    CAPSAICIN (UNII: S07O44R1ZM)  
    DICTAMNUS DASYCARPUS ROOT BARK (UNII: LA97176ILS)  
    ALCOHOL (UNII: 3K9958V90M)  
    ASIAN GINSENG (UNII: CUQ3A77YXI)  
    LIGUSTICUM SINENSE SUBSP. CHUANXIONG ROOT (UNII: RR83T99U97)  
    BIOTIN (UNII: 6SO6U10H04)  
    CARTHAMUS TINCTORIUS WHOLE (UNII: 5EMV416J82)  
    GINGER (UNII: C5529G5JPQ)  
    ARCTIUM LAPPA WHOLE (UNII: 73070DU1LA)  
    WATER (UNII: 059QF0KO0R)  
    REYNOUTRIA MULTIFLORA WHOLE (UNII: 85S46HFR8A)  
    MARINE COLLAGEN, SOLUBLE (UNII: 8JC99XGU4W)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:81653-013-0160 mL in 1 BOTTLE; Type 0: Not a Combination Product12/04/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other12/04/2023
    Labeler - Guangzhou Jianyuan Biological Technology Co., Ltd. (548120189)
    Establishment
    NameAddressID/FEIBusiness Operations
    Guangzhou Jianyuan Biological Technology Co., Ltd.548120189manufacture(81653-013)