Label: OLAY SENSITIVE ECZEMA THERAPY SKIN RELIEF SKIN PROTECTANT- colloidal oatmeal cream

  • NDC Code(s): 69423-699-48
  • Packager: The Procter & Gamble Manufacturing Company
  • 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 March 30, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredients

    Colloidal Oatmeal 1.0%

  • 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.

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

    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

  • Directions

    Apply as needed

  • INACTIVE INGREDIENT

    Water, glycerin, isohexadecane, niacinamide, dimethicone, isopropyl isostearate, stearyl alcohol, cetyl alcohol, hydrogenated shea butter, panthenol, palmitoyl pentapeptide-4, ethylhexylglycerin, hydroxyacetophenone, C13-14 isoparaffin, dimethiconol, laureth- 7, cetearyl glucoside, cetearyl alcohol, stearic acid, palmitic acid, behenyl alcohol, disodium EDTA, polyacrylamide, PEG-100 stearate, phenoxyethanol

  • Questions:

    1-800-285-5170

  • SPL UNCLASSIFIED SECTION

    Manufactured in USA from local and

    Imported Ingredients

    Distr. by PROCTER & GAMBLE,

    CINCINNATI, OH 45202

    www.olay.com

  • PRINCIPAL DISPLAY PANEL - 1.70 oz (48 g)

    OLAY

    SENSITIVE

    ECZEMA

    THERAPY

    Skin Relief Cream

    Colloidal Oatmeal

    Skin Protectant

    FRAGRANCE-FREE

    Net Wt. 48 g (1.7 oz)

    Olay

  • INGREDIENTS AND APPEARANCE
    OLAY SENSITIVE ECZEMA THERAPY SKIN RELIEF SKIN PROTECTANT 
    colloidal oatmeal cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69423-699
    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
    C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
    PALMITIC ACID (UNII: 2V16EO95H1)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    DIMETHICONOL (50000 CST) (UNII: R2285D73YT)  
    CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)  
    ISOHEXADECANE (UNII: 918X1OUF1E)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    PALMITOYL PENTAPEPTIDE-4 (UNII: KK181SM5JG)  
    LAURETH-7 (UNII: Z95S6G8201)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    ISOPROPYL ISOSTEARATE (UNII: C67IXB9Y7T)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)  
    POLYACRYLAMIDE (1300000 MW) (UNII: SC5Y4X78TG)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    DOCOSANOL (UNII: 9G1OE216XY)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69423-699-481 in 1 CARTRIDGE03/06/2023
    148 g in 1 JAR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalM01603/06/2023
    Labeler - The Procter & Gamble Manufacturing Company (004238200)
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