Label: VITABATH BABY ECZEMA CARE MOISTURE- colloidal oatmeal cream

  • 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 June 11, 2019

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  • Active Ingredients

    Colloidal Oatmeal 1% w/w

  • Purpose

    Skin protectant

  • Uses

    Temporarily protects and helps relieve minor skin irritation and itching due to •Eczema •Rashes

  • Warnings

    For external use only.

    When using this product

    • Avoid contact with eyes
  • WHEN USING

    When using this product do not get into eyes.

  • STOP USE

    Stop use and ask a doctor if

    • CONDITIONS WORSENS
    • SYMPTOMS LAST MORE THAN 7 DAYS OR CLEAR UP AND OCCUR AGAIN WITHIN A FEW DAYS.
  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN. If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    Apply as needed.

  • OTHER INFORMATION:

    •Remove quality seal •Do not use if quality seal is broken •For use on mild to moderate eczema or as directed by a physician •Store at room temperature

  • Inactive Ingredients

    Purified water
    Glycerin
    Distearyldimonium Chloride
    Isopropyl Palmitate
    Ricinus communis (Castor) Seed Oil
    Cetyl Alcohol
    Diheptyl Succinate
    Benzyl Alcohol
    Capryloyl Glycerin/Sebacic Acid Copolymer
    Sodium Hydroxide
    Steareth-20
    Hydrogenated Castor Oil
    Benzoic Acid
    Dl-Panthenol
    Beeswax
    Dehydroacetic Acid
    Sodium Chloride
    Copernicia Cerifera (Carnauba) Wax
    Tocopherol
    Avena Sativa (Oat) Kernel Extract
    Avena Sativa (Oat) Kernel Oil
    Ceramide NP

  • QUESTIONS

    Questions? Call toll-free 1-888-673-3377

  • PRINCIPAL DISPLAY PANEL

    Tube Label

  • INGREDIENTS AND APPEARANCE
    VITABATH BABY ECZEMA CARE MOISTURE 
    colloidal oatmeal cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73172-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OATMEAL (UNII: 8PI54V663Y) (OATMEAL - UNII:8PI54V663Y) OATMEAL1 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)  
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    OAT (UNII: Z6J799EAJK)  
    OAT KERNEL OIL (UNII: 3UVP41R77R)  
    CERAMIDE NP (UNII: 4370DF050B)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X)  
    ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
    STEARETH-20 (UNII: L0Q8IK9E08)  
    CASTOR OIL (UNII: D5340Y2I9G)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    DIHEPTYL SUCCINATE (UNII: 057N7SS26Y)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    CAPRYLOYL GLYCERIN/SEBACIC ACID COPOLYMER (2000 MPA.S) (UNII: N7YC58165T)  
    DEHYDROACETIC ACID (UNII: 2KAG279R6R)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73172-001-01226 g in 1 TUBE; Type 0: Not a Combination Product06/11/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34706/11/2019
    Labeler - Vitabath, Inc. (203461637)
    Establishment
    NameAddressID/FEIBusiness Operations
    Canadian Custom Packaging207062514manufacture(73172-001)
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