Label: HAIR TREATMENT PREMIUM- glycerin shampoo

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 May 28, 2020

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  • ACTIVE INGREDIENTS PURPOSE

    Glycerin 3.88 %.................... 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

    • Pour shampoo unto your hand and rub your palms to emulsify it, apply on hair and scalp, massage evenly for a few minutes and rinse throughly with water. Repeat to enhance its effects
    • For easier combining and better results, combine the product with Nuggela & Sule Extreme conditioner.

    • Pour shampoo unto your hand and rub your palms to emulsify it, apply on hair and scalp, massage evenly for a few minutes and rinse throughly with water. Repeat to enhance its effects
    • For easier combining and better results, combine the product with Nuggela & Sule Extreme conditioner.
  • Uses

    • Helps and protects the scalp and strengthens the hair
    • Replenish the hair providing regeneration and skin protection to the scalp.

  • Inactive Ingredients

    AQUA, SODIUM LAURETH SULFATE, MARIS SAL, METHYLPROPANEDIOL, COCAMIDE DEA, COCAMIDOPROPYL BETAINE, PEG-7 GLYCERYL COCOATE, DECYL GLUCOSIDE, PEG-150 DISTEARATE, GLYCOGEN, ALLIUM CEPA BULB EXTRACT, PEG-40 HYDROGENATED CASTOR OIL, ACRYLATES/STEARETH-20 METHACRYLATE COPOLYMER, PROPYLENE GLYCOL, PARFUM, PEG-55 PROPYLENE GLYCOL OLEATE, CAPRYLYL GLYCOL, METHOXY PEG/PPG-7/3 AMINOPROPYL DIMETHICONE, PEG/PPG-20/6 DIMETHICONE, PHENYL TRIMETHICONE, ETHOXYDIGLYCOL, SODIUM HYDROXIDE, PHENYLPROPANOL, CARAMEL, POLYQUATERNIUM-7, PHENOXYETHANOL, SODIUM LAURYL SULFATE, POTASSIUM SORBATE, SODIUM BENZOATE, SODIUM SUCCINATE, LIMONENE, LINALOOL, HEXYL CINNAMAL, CITRAL

  • Uses

    • Helps and protects the scalp and strengthens the hair
    • Replenish the hair providing regeneration and skin protection to the scalp.
  • Package Label

    Bottle

  • INGREDIENTS AND APPEARANCE
    HAIR TREATMENT PREMIUM 
    glycerin shampoo
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71578-006
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN3.88 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    PEG/PPG-20/6 DIMETHICONE (UNII: PWZ7N4UIKE) 0.5 mg  in 1 mL
    PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R) 0.5 mg  in 1 mL
    PHENYLPROPANOL (UNII: 0F897O3O4M) 0.07 mg  in 1 mL
    .ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I) 0.0001 mg  in 1 mL
    SODIUM CHLORIDE (UNII: 451W47IQ8X) 4 mg  in 1 mL
    SODIUM LAURYL SULFATE (UNII: 368GB5141J) 0.0112 mg  in 1 mL
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4) 0.0025 mg  in 1 mL
    METHOXY PEG/PPG-7/3 AMINOPROPYL DIMETHICONE (UNII: 4M7P1JZ2V2) 0.5 mg  in 1 mL
    PEG-10 ACRYLATE (UNII: F4663X97LW) 0.6 mg  in 1 mL
    ETHYL ACRYLATE/METHACRYLIC ACID/STEARETH-20 METHACRYLATE COPOLYMER (UNII: EPA1872R1N) 0.84 mg  in 1 mL
    CITRAL (UNII: T7EU0O9VPP) 0.001 mg  in 1 mL
    ONION (UNII: 492225Q21H) 0.02 mg  in 1 mL
    SODIUM LAURETH SULFATE (UNII: BPV390UAP0) 8.91 mg  in 1 mL
    COCO DIETHANOLAMIDE (UNII: 92005F972D) 2 mg  in 1 mL
    DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B) 0.3 mg  in 1 mL
    CARAMEL (UNII: T9D99G2B1R) 0.048 mg  in 1 mL
    SODIUM SUCCINATE HEXAHYDRATE (UNII: U16QOD6C4E) 0.01 mg  in 1 mL
    SODIUM HYDROXIDE (UNII: 55X04QC32I) 0.08 mg  in 1 mL
    DECYL GLUCOSIDE (UNII: Z17H97EA6Y) 1 mg  in 1 mL
    PEG-150 DISTEARATE (UNII: 6F36Q0I0AC) 1 mg  in 1 mL
    PEG-7 GLYCERYL COCOATE (UNII: VNX7251543) 1.5 mg  in 1 mL
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) 1.8 mg  in 1 mL
    LINALOOL, (-)- (UNII: 3U21E3V8I2) 0.0001 mg  in 1 mL
    WATER (UNII: 059QF0KO0R) 100 mg  in 1 mL
    PHENOXYETHANOL (UNII: HIE492ZZ3T) 0.015 mg  in 1 mL
    POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600000 MW) (UNII: 0L414VCS5Y) 0.04 mg  in 1 mL
    METHYLPROPANEDIOL (UNII: N8F53B3R4R) 2.4 mg  in 1 mL
    SODIUM BENZOATE (UNII: OJ245FE5EU) 0.0025 mg  in 1 mL
    PROPANEDIOL (UNII: 5965N8W85T) 0.825 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) 0.05 mg  in 1 mL
    PEG-40 CASTOR OIL (UNII: 4ERD2076EF) 0.97 mg  in 1 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71578-006-01250 mL in 1 BOTTLE; 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(71578-006)
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