Label: DERMA BREEZE SKIN PROTECTANT CREAM- 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 November 20, 2015

If you are a consumer or patient please visit this version.

View All Sections
  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Colloidal oatmeal 1%

  • Purpose

    Skin protectant

  • Uses

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

    • rashes
    • eczema
  • 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 immediately

  • Directions

    • apply as needed
  • Inactive ingredients

    Water, Medium-Chain Triglycerides, Distearyldimonium Chloride, Saccharide Isomerate, Cetostearyl alcohol, Isocetyl Stearate, Curdlan, Lactic Acid,Glyceryl Monostearate, PPG-51/SMDI Copolymer, Phenoxyethanol, Cetyl Alcohol, Propylene Glycol Stearate, Sodium Chloride, Alpha-Tocopherol Acetate, PEG-10 Soy Sterol

  • Questions or comments?

    1-828-507-7177

  • PRINCIPAL DISPLAY PANEL

    Derma Breeze

    1% colloidal oatmeal

    WITH TRILEXON

    SKIN PROTECTANT

    CREAM

    Relieves symptoms of dry skin

    Gentle Daily Use Formula

    Steroid Free

    Fragrance Free

    Oil Free Substance

    db1

    db2

    db

  • INGREDIENTS AND APPEARANCE
    DERMA BREEZE SKIN PROTECTANT CREAM 
    colloidal oatmeal cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69475-5411
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OATMEAL (UNII: 8PI54V663Y) (OATMEAL - UNII:8PI54V663Y) OATMEAL10 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    CURDLAN (UNII: 6930DL209R)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    ISOCETYL STEARATE (UNII: 3RJ7186O9W)  
    SACCHARIDE ISOMERATE (UNII: W8K377W98I)  
    LACTIC ACID (UNII: 33X04XA5AT)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    PPG-51/SMDI COPOLYMER (UNII: KQ9JG3O3YA)  
    WATER (UNII: 059QF0KO0R)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    PROPYLENE GLYCOL STEARATE (UNII: MZM1I680W0)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    PEG-10 SOY STEROL (UNII: FG54K98L0Q)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69475-5411-028.35 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:69475-5411-11000 g in 1 CONTAINER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34709/15/2015
    Labeler - Greyson International, Inc. (848379215)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!