Label: VITABATH BABY ECZEMA CARE INTENSIVE BALM- 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 13, 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 do not get into eyes.

  • STOP USE

    Stop use and ask a doctor if • condition 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

    Directions: Apply as needed.

  • OTHER INFORMATION

    Other Information: •Remove quality seal. •Do not use if quality seal is broken. •Protect from
    excessive heat (40°C/104°F).

  • Inactive Ingredients

    Purified Water
    Glycerin
    Cetearyl Alcohol
    Isopropyl Palmitate
    Cetyl Alcohol
    Caprylic/Capric Triglyceride
    Sodium Stearoyl Glutamate
    Stearic Acid
    Benzyl Alcohol
    Diheptyl Succinate
    Potassium Phosphate Monobasic
    Capryloyl Glycerin/Sebacic Acid Copolymer
    Citric Acid
    Sodium Hydroxide
    Benzoic Acid
    Dehydroacetic Acid
    Tocopherol
    Avena Sativa (Oat) Kernel Extract
    Avena Sativa (Oat) Kernel Oil
    Ceramide NP
    Dipotassium Phosphate

  • QUESTIONS

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

  • PRINCIPAL DISPLAY PANEL

    Jar Label

  • INGREDIENTS AND APPEARANCE
    VITABATH BABY ECZEMA CARE INTENSIVE BALM 
    colloidal oatmeal cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73172-003
    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
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    DEHYDROACETIC ACID (UNII: 2KAG279R6R)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    OAT KERNEL OIL (UNII: 3UVP41R77R)  
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    OAT (UNII: Z6J799EAJK)  
    CERAMIDE NP (UNII: 4370DF050B)  
    POTASSIUM PHOSPHATE, MONOBASIC (UNII: 4J9FJ0HL51)  
    CAPRYLOYL GLYCERIN/SEBACIC ACID COPOLYMER (2000 MPA.S) (UNII: N7YC58165T)  
    DIBASIC POTASSIUM PHOSPHATE (UNII: CI71S98N1Z)  
    DIHEPTYL SUCCINATE (UNII: 057N7SS26Y)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73172-003-01312 g in 1 JAR; Type 0: Not a Combination Product06/13/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34706/13/2019
    Labeler - Vitabath Inc. (203461637)
    Establishment
    NameAddressID/FEIBusiness Operations
    Canadian Custom Packaging Comapany207062514manufacture(73172-003)
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