Label: DIABETIC ITCH RELIEF CREAM PROFESSIONAL- 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 May 9, 2021

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  • Active Ingredient

    Colloidal Oatmeal 1%......................Skin Protectant

  • 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

    Store at room temperature 20° – 25°C (68° – 77°F).

  • Inactive Ingredients

    Aqua, Glycerin, Inula Viscosa Flower/Leaf/Stem Extract, Xanthan Gum, Glyceryl Stearate Citrate, Aloe Barbadensis Leaf Juice, Propanediol-1,3, Cetyl Alcohol, Sodium Benzoate, Potassium Sorbate, Biosaccharide Gum-1, Tocopheryl Acetate (Vitamin E), Sodium Gluconate, Citric Acid.

  • Questions?

    Call toll free 1-844-474-2552 or visit www.lavior.com

  • PRINCIPAL DISPLAY PANEL

    Diabetic Itch Relief Pro

  • INGREDIENTS AND APPEARANCE
    DIABETIC ITCH RELIEF CREAM PROFESSIONAL 
    colloidal oatmeal cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71521-024
    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
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    BIOSACCHARIDE GUM-1 (UNII: BB4PU4V09H)  
    SODIUM GLUCONATE (UNII: R6Q3791S76)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    GLYCERYL STEARATE CITRATE (UNII: WH8T92A065)  
    DITTRICHIA VISCOSA WHOLE (UNII: 3SYW69FH88)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71521-024-5050 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product03/31/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34703/31/2021
    Labeler - Lavior Inc (080685327)
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