Label: 3-IN-1 RELIEF CVS- colloidal oatmeal - 1.00% lotion

  • 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 December 8, 2017

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  • Active ingredient                            Purpose

    Colloidal Oatmeal - 1.00%.................................Skin Protectant

  • Uses

    temporarily protects and helps relieve minor skin irritations and itching due to: • eczema • rashes

  • Warning

    For external use only.

    When using this product • do not get into eyes. 

    Stop use and ask a doctor if • condition worsens • symptoms persist for 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.

  • DOSAGE & ADMINISTRATION

    Directions • Apply as needed

  • Inactive ingredients

    Water, Glycerin, Distearyldimonium Chloride, Petrolatum, Panthenol, Isopropyl Palmitate, Cetyl Alcohol, Dimethicone, Avena Sativa (Oat) , Kernel Oil, Avena Sativa (Oat) Kernel Extract, Cucumis Sativus (Cucumber) Fruit Extract, Aloe Barbadensis Leaf Extract, Chamomilla Recutita , Matricaria) Flower Extract, Ceramide NP, Sorbitol, Lecithin, Xanthan Gum, Oleic Acid, Iron Oxides, Sodium Chloride, Steareth-20, Pentylene , Glycol, 4-t-Butylcyclohexanol, Propylene Glycol, Benzalkonium Chloride

  • PURPOSE

  • PRINCIPAL DISPLAY PANEL

    image descriptionimage description

  • INGREDIENTS AND APPEARANCE
    3-IN-1 RELIEF  CVS
    colloidal oatmeal - 1.00% lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59779-451
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OATMEAL (UNII: 8PI54V663Y) (OATMEAL - UNII:8PI54V663Y) OATMEAL1.0 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Glycerin (UNII: PDC6A3C0OX)  
    Distearyldimonium Chloride (UNII: OM9573ZX3X)  
    Petrolatum (UNII: 4T6H12BN9U)  
    Panthenol (UNII: WV9CM0O67Z)  
    Isopropyl Palmitate (UNII: 8CRQ2TH63M)  
    Cetyl Alcohol (UNII: 936JST6JCN)  
    OAT KERNEL OIL (UNII: 3UVP41R77R)  
    OAT (UNII: Z6J799EAJK)  
    Dimethicone (UNII: 92RU3N3Y1O)  
    Cucumber (UNII: YY7C30VXJT)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CHAMOMILE (UNII: FGL3685T2X)  
    CERAMIDE NP (UNII: 4370DF050B)  
    Sorbitol (UNII: 506T60A25R)  
    Xanthan Gum (UNII: TTV12P4NEE)  
    Oleic Acid (UNII: 2UMI9U37CP)  
    FERROUS OXIDE (UNII: G7036X8B5H)  
    Sodium Chloride (UNII: 451W47IQ8X)  
    Steareth-20 (UNII: L0Q8IK9E08)  
    Pentylene Glycol (UNII: 50C1307PZG)  
    4-TERT-BUTYLCYCLOHEXANOL (UNII: K0H1405S9C)  
    Propylene Glycol (UNII: 6DC9Q167V3)  
    Benzalkonium Chloride (UNII: F5UM2KM3W7)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59779-451-05170 g in 1 BOTTLE; Type 0: Not a Combination Product11/30/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34711/30/2015
    Labeler - CVS (062312574)
    Registrant - Product Quest Mfg (927768135)
    Establishment
    NameAddressID/FEIBusiness Operations
    Product Quest Mfg927768135manufacture(59779-451) , label(59779-451)
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