Label: BABY LOVE ECZEMA THERAPY- 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 September 7, 2023

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  • Active ingredient

    Colloidal oatmeal 1%

  • Purpose

    Skin protectant

  • Uses

    temporarily protects and helps relieve minor skin irritation and itching due to:

    ■ rashes ■ eczema

    ■ poison ivy, oak, or sumac ■ insect bites

    .

  • Warnings

    For external use only

  • When using this product

    ■ do not get into eyes

  • 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

    If swallowed, get medical help or contact a Poison Control Center right away

  • Directions

    apply as needed

  • Other information

    ■ do not use if tube seal under cap is broken or missing ■ store at room temperature

  • Inactive ingredients

    water, petrolatum, cetyl alcohol, steareth-20, glycerin, steareth-2, isopropyl palmitate,dimethicone, avena sativa (oat) kernel extract, panthenol, benzalkonium chloride, sodium chloride, benzyl alcohol

  • Package Label

    package label

  • INGREDIENTS AND APPEARANCE
    BABY LOVE  ECZEMA THERAPY
    colloidal oatmeal cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:20276-510
    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
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    STEARETH-2 (UNII: V56DFE46J5)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    OAT KERNEL OIL (UNII: 3UVP41R77R)  
    STEARETH-20 (UNII: L0Q8IK9E08)  
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:20276-510-0256.7 g in 1 TUBE; Type 0: Not a Combination Product10/04/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalM01610/04/2021
    Labeler - Delta Brands Inc (102672008)
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