HAIR REGENERATOR (GLYCERIN) SOLUTION [NUGGELA & SULE SL]

HAIR REGENERATOR (GLYCERIN) SOLUTION [NUGGELA & SULE SL]
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NDC 71578-002-01
Set ID 5589d55f-ad95-6b80-e054-00144ff88e88
Category HUMAN OTC DRUG LABEL
Packager NUGGELA & SULE SL
Generic Name
Product Class
Product Number
Application Number PART347
  • ACTIVE INGREDIENTS PURPOSE

    Glycerin 4%.................... Skin Protectant

  • Warnings

    For external use only.

    Do not use on damaged or broken skin.

    Stop use and ask a doctor if rash occurs.

    Keep out of reach of children.

    Whhen using this product do not get into eyes.

    Children under 6 months: as a doctor.

    WARNINGS

    Stop use and ask a doctor if rash occurs

    Children under 6 months: ask a doctor

    Warnings

    Keep out of reach of children

  • Questions or comments?

    + 305 670 0979 M-F 9:00 am to 5:00 pm

  • Other Information

    . keep the product in a cool and dry place

  • Directions

    • apply one dose every 2 days for a minimun of 30 days
    • for better results, combine this product with Nuggela & Sule Premium shampoo and Conditioner

    • apply one dose every 2 days for a minimun of 30 days
    • for better results, combine this product with Nuggela & Sule Premium shampoo and Conditioner
  • Uses

    • regenerates and stimulates the hair
    • nourish the scalp and provides the needed strenght to the broken and damaged hair
    • provides skin protection to the scalp

  • Inactive Ingredients

    AQUA, ALCOHOL DENAT, PROPYLENE GLYCOL, PLACENTAL PROTEIN, METHYLPROPANEDIOL, HYDROLYZED SOY PROTEIN, PROPANEDIOL, CAPRYLYL GLYCOL, GLYCOGEN, POLYQUATERNIUM-11, PEG-40 HYDROGENATED CASTOR OIL

    DISODIUM EDTA, PHENOXYETHANOL, PARFUM, PANTHENOL, ZINC PCA, GLUCOSE, PHENYLPROPANOL, ORNITHINE HCL, NIACINAMIDE, ARGININE HCL, CHLORPHENESIN, LEPIDIUM MEYENII ROOT EXTRACT, PYRIDOXINE HCL, GLUCOSAMINE HCL, CITRULLINE, SODIUM SUCCINATE, SODIUM HYDROXIDE,SORBIC ACID, BIOTIN, D&C Yellow No. 5, FD&C Blue No.1, LIMONENE, LINALOOL

  • Uses

    • regenerates and stimulates the hair
    • nourish the scalp and provides the needed strenght to the broken and damaged hair
    • provides skin protection to the scalp
  • Package Label

    Box

  • INGREDIENTS AND APPEARANCE
    HAIR REGENERATOR 
    glycerin solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71578-002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN4 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    PANTHENOL (UNII: WV9CM0O67Z) 0.106 mg  in 1 mL
    LEPIDIUM MEYENII ROOT (UNII: HP7119212T) 0.03 mg  in 1 mL
    PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) 0.02 mg  in 1 mL
    CHLORPHENESIN (UNII: I670DAL4SZ) 0.03 mg  in 1 mL
    GLUCOSAMINE HYDROCHLORIDE (UNII: 750W5330FY) 0.02 mg  in 1 mL
    CITRULLINE (UNII: 29VT07BGDA) 0.02 mg  in 1 mL
    SODIUM SUCCINATE HEXAHYDRATE (UNII: U16QOD6C4E) 0.01 mg  in 1 mL
    SODIUM HYDROXIDE (UNII: 55X04QC32I) 0.0044 mg  in 1 mL
    SORBIC ACID (UNII: X045WJ989B) 0.002 mg  in 1 mL
    ALCOHOL (UNII: 3K9958V90M) 10 mg  in 1 mL
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M) 0.0001 mg  in 1 mL
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD) 0.0001 mg  in 1 mL
    BIOTIN (UNII: 6SO6U10H04) 0.002 mg  in 1 mL
    LINALOOL, (-)- (UNII: 3U21E3V8I2) 0.0001 mg  in 1 mL
    WATER (UNII: 059QF0KO0R) 64.33 mg  in 1 mL
    DIPROPYLENE GLYCOL (UNII: E107L85C40) 6.82 mg  in 1 mL
    PHENOXYETHANOL (UNII: HIE492ZZ3T) 0.17 mg  in 1 mL
    HYDROLYZED PLACENTAL PROTEIN (BOVINE) (UNII: KR5CS6RBH9) 6.53 mg  in 1 mL
    METHYLPROPANEDIOL (UNII: N8F53B3R4R) 2.4 mg  in 1 mL
    SOY PROTEIN (UNII: R44IWB3RN5) 1.97 mg  in 1 mL
    PROPANEDIOL (UNII: 5965N8W85T) 0.98 mg  in 1 mL
    LIMONENE, (+)- (UNII: GFD7C86Q1W) 0.01 mg  in 1 mL
    CAPRYLYL GLYCOL (UNII: 00YIU5438U) 0.52 mg  in 1 mL
    GLYCOGEN (UNII: 309GSC92U1) 0.5 mg  in 1 mL
    POLYQUATERNIUM-11 (1000000 MW) (UNII: 0B44BS5IJS) 0.4 mg  in 1 mL
    PEG-40 CASTOR OIL (UNII: 4ERD2076EF) 0.25 mg  in 1 mL
    EDETATE DISODIUM (UNII: 7FLD91C86K) 0.2 mg  in 1 mL
    ZINC PIDOLATE (UNII: C32PQ86DH4) 0.1 mg  in 1 mL
    DEXTROSE (UNII: IY9XDZ35W2) 0.1 mg  in 1 mL
    PHENYLPROPANOL (UNII: 0F897O3O4M) 0.07 mg  in 1 mL
    ORNITHINE HYDROCHLORIDE (UNII: HBK84K66XH) 0.07 mg  in 1 mL
    NIACINAMIDE (UNII: 25X51I8RD4) 0.07 mg  in 1 mL
    ARGININE HYDROCHLORIDE (UNII: F7LTH1E20Y) 0.07 mg  in 1 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71578-002-0110 mL in 1 BOX, UNIT-DOSE; Type 0: Not a Combination Product07/27/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34707/27/2017
    Labeler - NUGGELA & SULE SL (466134663)
    Registrant - NUGGELA & SULE SL (466134663)
    Establishment
    NameAddressID/FEIBusiness Operations
    NUGGELA & SULE SL466134663manufacture(71578-002)

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