Label: CVS PHARMACY HYDRATING- 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 18, 2015

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

  • ACTIVE INGREDIENT

    Active Ingredient

    Colloidal Oatmeal 1%

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  • PURPOSE

    Purpose

    Skin protectant

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  • INDICATIONS & USAGE

    Uses

    Temporarily protects and helps relieve minor skin irritation and

    itching due to:  -Eczema   -Rashes

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  • WARNINGS

    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 for more than 7 days or clear up and occur

    again within a few days

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  • 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.

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  • DOSAGE & ADMINISTRATION

    Directions  -apply as needed

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  • OTHER SAFETY INFORMATION

    Other Information  -For use on mild to moderate

    eczema or as directed by a physician. Store at room temperature.

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  • INACTIVE INGREDIENT

    Inactive Ingredients  water, glycerin, distearyldimonium

    chloride, Isopropyl palmitate, cetearyl alcohol, dimethicone,

    steareth-21, panthenol (pro-vitamin B5), benzalkonium chloride,

    sodium chloride, ceramide NP, ceramide AP, ceramide EOP,

    phytosphingosine, chloresterol, sodium lauroyl lactylate, carbomer,

    xanthan gum, avena sativa (oat) kernel oil, avena sativa (oat) kernel

    extract, avena sativa (oat) kernel flour.

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  • INGREDIENTS AND APPEARANCE
    CVS PHARMACY  HYDRATING
    colloidal oatmeal cream
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:59779-929
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    OATMEAL (UNII: 8PI54V663Y) (OATMEAL - UNII:8PI54V663Y) OATMEAL .001 mg  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X)  
    ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    STEARETH-21 (UNII: 53J3F32P58)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    CERAMIDE 3 (UNII: 4370DF050B)  
    CERAMIDE 6 II (UNII: F1X8L2B00J)  
    PHYTOSPHINGOSINE (UNII: GIN46U9Q2Q)  
    CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)  
    SODIUM LAUROYL LACTYLATE (UNII: 7243K85WFO)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    OAT (UNII: Z6J799EAJK)  
    CHOLESTEROL (UNII: 97C5T2UQ7J)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:59779-929-15 140 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part347 05/01/2015
    Labeler - CVS Pharmacy (062312574)
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