Label: SKIN THERAPY CALM- colloidal oatmeal 1 % 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 October 21, 2021

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

View All Sections
  • Active ingredient

    Colloidal Oatmeal 1%

  • Purpose

    Skin protectant

  • Uses

    Temporarily protects and helps relieve minor skin irritation and itching due to

    eczema, poison oak, ivy, or sumac, rashes, insect bites .

  • Warnings


    For external use only.

  • 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 to affected skin 2-3 times daily.

  • Inactive ingredients

    Inactive ingredients: Water, Organic Aloe Barbadensis Leaf Juice, Thuja Orientalis Extract, Scutellaria Baicalensis Root Extract, Phellodendron Amurense Bark Extract, Coptis Chinesis Root Extract, Hyssopus Officinalis Extract, Atractylodes Lancea Root Extract, Lonicera Japonica Stem Extract, Dictamnus Desycarpus Root Extract, Organic Olea Europaea (Olive) Oil, Glycerin (plant derived), Cetearyl Alcohol, Cetearyl Glucoside, Caprylic Capric Triglycerides , Glyceryl Stearate (plant derived), Isopropyl Palmitate (plant derived), Niacinamide, Phenethyl Alcohol, Caprylyl Glycol, Ethylhexyl Glycerin, C10-18 Triglycerides, Allantoin, Sodium PCA , Linoleic Acid, Tocopherol.

  • Stop use and ask a doctor if...

    Stop use and ask a doctor if symptoms worsen, or do not improve after regular use of this product as directed. Avoid contact with eyes.

  • PRINCIPAL DISPLAY PANEL

    Box

    Tube

  • INGREDIENTS AND APPEARANCE
    SKIN THERAPY CALM 
    colloidal oatmeal 1 % cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70597-117
    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
    LONICERA JAPONICA WHOLE (UNII: UV4X7MQQ43)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    ATRACTYLODES LANCEA ROOT OIL (UNII: EC228KGY00)  
    ALLANTOIN, (+)- (UNII: XDK458E1J9)  
    C10-18 TRIGLYCERIDES (UNII: 43AGM4PHPI)  
    CAPRYLIC/CAPRIC/LAURIC TRIGLYCERIDE (UNII: FJ1H6M2JG9)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)  
    COPTIS CHINENSIS ROOT (UNII: CXS4LJR7EL)  
    DICTAMNUS DASYCARPUS ROOT (UNII: 6153LEN214)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
    HYSSOPUS OFFICINALIS FLOWERING TOP (UNII: X7HKN4FOJI)  
    WATER (UNII: 059QF0KO0R)  
    LINOLEIC ACID (UNII: 9KJL21T0QJ)  
    ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
    SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    PHELLODENDRON AMURENSE BARK (UNII: PBG27B754G)  
    PHENYLETHYL ALCOHOL (UNII: ML9LGA7468)  
    SCUTELLARIA BAICALENSIS ROOT (UNII: 7J95K7ID2S)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    PLATYCLADUS ORIENTALIS WHOLE (UNII: 835370K47L)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70597-117-151 in 1 BOX06/01/2017
    142.5 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34706/01/2017
    Labeler - Harmony Herbal (071401048)
    Registrant - Harmony Herbal (071401048)
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!