Label: JNH ATO-CARE SUPER BARRIED ATO-SERUM- ceramide 3 liquid

  • 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 August 24, 2012

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  • ACTIVE INGREDIENT

    ceramide 3
  • INACTIVE INGREDIENT

    - Water - Cholesterol - Caprylic/Capric Triglyceride - Magnesium Aspartate - Zinc Gluconate - Portulaca Oleracea Extract – Phytosphingosine - Hydrogenated Lecithin - Oleic Acid - Stearic Acid - Butylene Glycol – Betaine - Lactic Acid - Copper Gluconate - Sodium PCA - Hamamelis Virginiana (Witch Hazel) Leaf Extract - Chamaecyparis Obtusa Oil - Sorbitol - Serine – Glycine - Glutamic Acid - Alanine - Lysine - Arginine - Threonine - Proline - Sodium Hydroxide - Phenoxyethanol - Methylparaben - Propylparaben - Ethylparaben - Isobutylparaben - Butylparaben
  • PURPOSE

    moisturizer for atopic skin
  • KEEP OUT OF REACH OF CHILDREN

    keep out of reach of the children
  • INDICATIONS & USAGE

    - Clean your skin first and apply the suitable amount of ATO serum, smoothly tap with fingers.
    - After taking a shower or washing your face, dry up water first then put the Serum where you feel dry or itchy.
    - If you ever feel dryness or sensitiveness from your skin, apply the Serum with controlling the amount.
  • WARNINGS

    When using this product
    - keep out of eyes, ears, and mouth.  If contact occurs, rinse with plenty of cold water right away and contact a physician.  If swallowing, drink plenty of water and contact a physician
  • DOSAGE & ADMINISTRATION

    for external use only
  • PRINCIPAL DISPLAY PANEL

    package label
  • INGREDIENTS AND APPEARANCE
    JNH ATO-CARE SUPER BARRIED ATO-SERUM  
    ceramide 3 liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53010-3001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CERAMIDE 3 (UNII: 4370DF050B) (CERAMIDE 3 - UNII:4370DF050B) CERAMIDE 31.5 mg  in 50 mL
    Inactive Ingredients
    Ingredient NameStrength
    CHOLESTEROL (UNII: 97C5T2UQ7J)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    MAGNESIUM ASPARTATE (UNII: R17X820ROL)  
    ZINC GLUCONATE (UNII: U6WSN5SQ1Z)  
    PORTULACA OLERACEA WHOLE (UNII: D5J3623SV2)  
    PHYTOSPHINGOSINE (UNII: GIN46U9Q2Q)  
    HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)  
    OLEIC ACID (UNII: 2UMI9U37CP)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    BETAINE (UNII: 3SCV180C9W)  
    LACTIC ACID (UNII: 33X04XA5AT)  
    COPPER GLUCONATE (UNII: RV823G6G67)  
    SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)  
    WITCH HAZEL (UNII: 101I4J0U34)  
    CHAMAECYPARIS OBTUSA WOOD OIL (UNII: P2OMP71Y62)  
    SORBITOL (UNII: 506T60A25R)  
    SERINE (UNII: 452VLY9402)  
    GLYCINE (UNII: TE7660XO1C)  
    ALANINE (UNII: OF5P57N2ZX)  
    LYSINE (UNII: K3Z4F929H6)  
    ARGININE (UNII: 94ZLA3W45F)  
    THREONINE (UNII: 2ZD004190S)  
    PROLINE (UNII: 9DLQ4CIU6V)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    ETHYLPARABEN (UNII: 14255EXE39)  
    ISOBUTYLPARABEN (UNII: 0QQJ25X58G)  
    BUTYLPARABEN (UNII: 3QPI1U3FV8)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53010-3001-150 mL in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other08/24/2012
    Labeler - Daeduck Lab Co., Ltd (557819376)
    Registrant - Daeduck Lab Co., Ltd (557819376)
    Establishment
    NameAddressID/FEIBusiness Operations
    Daeduck Lab Co., Ltd557819376manufacture(53010-3001)