Label: 16BKOUTY NALL FUNGUS RENEWAL liquid

  • NDC Code(s): 84422-101-01
  • Packager: Shenzhen Graceful Cosmetics Co., Ltd
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated July 27, 2024

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

  • WARNINGS

    If you experience any discomfort, please stop using and seek medical attention promptly

  • CLEANING, DISINFECTING, AND STERILIZATION INSTRUCTIONS

    2

  • DOSAGE & ADMINISTRATION

    【 Instructions 】 Take an appropriate amount of this product and apply it to the surface of the skin.Once in the morning and once in the evening.

  • INACTIVE INGREDIENT

    123

  • INDICATIONS & USAGE

    789

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children 5

  • PURPOSE

    6This product is used for skin antibacterial purposes

  • PRINCIPAL DISPLAY PANEL

    3

  • INGREDIENTS AND APPEARANCE
    16BKOUTY NALL FUNGUS RENEWAL 
    16bkouty nall fungus renewal liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:84422-101
    Route of AdministrationCUTANEOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PHELLODENDRINE (UNII: AR68S526RB) (PHELLODENDRINE - UNII:AR68S526RB) PHELLODENDRINE1 g  in 100 mL
    UNDECYLENIC ACID (UNII: K3D86KJ24N) (UNDECYLENIC ACID - UNII:K3D86KJ24N) UNDECYLENIC ACID10 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    MENTHOL (UNII: L7T10EIP3A)  
    CAMPHOR OIL (UNII: 75IZZ8Y727)  
    ACETIC ACID (UNII: Q40Q9N063P)  
    SILVER CATION (UNII: 57N7B0K90A)  
    PROTOSTEPHANINE (UNII: 8HEL0402TN)  
    LONICERA CAPRIFOLIUM FLOWER (UNII: 5N1WD9784U)  
    AINSLIAEA FRAGRANS WHOLE (UNII: 5FG998PBC2)  
    PLATYCLADUS ORIENTALIS LEAF (UNII: 32E5V7G32B)  
    CHLORHEXIDINE ACETATE (UNII: 5908ZUF22Y) 0.2 g  in 100 mL
    LEONURINE (UNII: 09Q5W34QDA)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    COMMIPHORA MYRRHA WHOLE (UNII: UU81N77RI7)  
    BORNEOL (UNII: M89NIB437X)  
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    SOPHORA FLAVESCENS ROOT (UNII: IYR6K8KQ5K)  
    CROCUS SATIVUS FLOWER (UNII: 00IF91KFKQ)  
    IMPATIENS BALSAMINA FLOWER (UNII: 3169PS5TJH)  
    SMILACIN (UNII: 7913T95W7U)  
    PURSLANE (UNII: M6S840WXG5)  
    CYRTOMIUM FORTUNEI WHOLE (UNII: KVO7W5ZIG8)  
    EUCALYPTUS SMITHII OIL (UNII: X4023CB3OK)  
    ALOE FEROX LEAF (UNII: 0D145J8EME)  
    STEPHANIA JAPONICA WHOLE (UNII: 9R6ON4417X)  
    GLEDITSIA SINENSIS THORN (UNII: 26LKE578NY)  
    ISATIDINE (UNII: 51819GRV4U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:84422-101-0130 mL in 1 BOTTLE; Type 6: Drug/Biologic Combination06/25/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00506/25/2024
    Labeler - Shenzhen Graceful Cosmetics Co., Ltd (449897665)
    Registrant - Shenzhen Graceful Cosmetics Co., Ltd (449897665)
    Establishment
    NameAddressID/FEIBusiness Operations
    Shenzhen Graceful Cosmetics Co., Ltd449897665manufacture(84422-101) , label(84422-101)