Label: BUDDATE REGES INTENSIVE TREATMENT (butylene glycol, hydrogenated coconut oil, butyrospermum parkii- shea butter, palmitoyl tripeptide-1, palmitoyl tetrapeptide-7 cream

  • 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 February 17, 2019

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  • ACTIVE INGREDIENT

    Butylene Glycol: 5.57 %vv

    Hydrogenated Coconut Oil: 4.00 %vv

    Butyrospermum Parkii (Shea) Butter: 3.00%vv

    Palmitoyl Tripeptide-1: 0.000006 %vv

    Palmitoyl Tetrapeptide-7: 0.000006 %vv

  • INACTIVE INGREDIENT

    Water, Squalane, Triethylhexanoin, 1,2-hexanediol, Cyclomethicone, Stearyl Alcohol, Cetearyl olivate, Simmondsia Chinensis (JoJoba) Seed Oil, BeesWax, Sorbitan olivate, Polyglyceryl-3 Methylglucose Distearate, Phytosterols, Panthenol, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Arginine, Lecithin, Lavandula Intermedia Oil, Citrus Paradisi (Grapefruit) Peel Oil, Ethylhexylglycerin, Disodium EDTA, Cetyl Hydroxyethylcellulose, Rutin, Phaseolus Lunatus (Green Bean) Seed Extract, Caprylyl Glycol

  • PURPOSE

    Humectant & Skin Conditionnig (Protectant)

  • KEEP OUT OF REACH OF CHILDREN

    keep out of reach of the children

  • INDICATIONS & USAGE

    Apply a generous amount of the cream three times a day to your body needing to be nourishd, and then softly massage your skin.

  • WARNINGS

    1. For external use only.

    1) Do not use over the wound and irritated skin with eczema or infections

    2) Discontinue using the product if signs of irritations and/or rashes occur and seek professional medical help

    2. Keep the cover closed tight after use

    3. Do not put the left over contents back into the container to avoid deterioration

    1) Avoid contact with eyes

    2) Keep out of reach of children

    3) Store in a cool and dry place, away from direct sun light

  • DOSAGE & ADMINISTRATION

    for external use only


  • PRINCIPAL DISPLAY PANEL

    1

  • INGREDIENTS AND APPEARANCE
    BUDDATE REGES INTENSIVE TREATMENT 
    butylene glycol, hydrogenated coconut oil, butyrospermum parkii (shea) butter, palmitoyl tripeptide-1, palmitoyl tetrapeptide-7 cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71173-3000
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PALMITOYL TETRAPEPTIDE-7 (UNII: Q41S464P1R) (PALMITOYL TETRAPEPTIDE-7 - UNII:Q41S464P1R) PALMITOYL TETRAPEPTIDE-70.000006 g  in 100 mL
    SHEA BUTTER (UNII: K49155WL9Y) (SHEA BUTTER - UNII:K49155WL9Y) SHEA BUTTER3 g  in 100 mL
    PALMITOYL TRIPEPTIDE-1 (UNII: RV743D216M) (PALMITOYL TRIPEPTIDE-1 - UNII:RV743D216M) PALMITOYL TRIPEPTIDE-10.000006 g  in 100 mL
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA) (BUTYLENE GLYCOL - UNII:3XUS85K0RA) BUTYLENE GLYCOL5.57 g  in 100 mL
    HYDROGENATED COCONUT OIL (UNII: JY81OXM1OM) (HYDROGENATED COCONUT OIL - UNII:JY81OXM1OM) HYDROGENATED COCONUT OIL4 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71173-3000-170 mL in 1 TUBE; Type 0: Not a Combination Product01/01/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other01/01/2017
    Labeler - BUDDATE Co Ltd (694462588)
    Registrant - BUDDATE Co Ltd (694462588)
    Establishment
    NameAddressID/FEIBusiness Operations
    BUDDATE Co Ltd694462588manufacture(71173-3000)