Label: ECZEMA CARE- oatmeal lotion

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 12/12

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

  • ACTIVE INGREDIENT

    COLLOIDAL OATMEAL 1.0%

    PURPOSE

    SKIN PROTECTANT

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  • USES

    TEMPORARILY PROTECTS AND HELPS RELIEVE MINOR SKIN ITCHING AND IRRITATION DUE TO ECZEMA.

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  • WARNINGS

    FOR EXTERNAL USE ONLY.

    WHEN USING THIS PRODUCT

    AVOID CONTACT WITH EYES. IF CONTACT OCCURS, RINSE THOROUGHLY WITH WATER.

    STOP USING THIS PRODUCT AND ASK A DOCTOR IF

    CONDITION WORSENS, OR IF SYMPTOMS LAST MORE THAN 7 DAYS, OR IF THEY CLEAR UP AND OCCUR AGAIN WITHIN A FEW DAYS.

    KEEP OUT OF REACH OF CHILDREN

    IN CASE OF ACCIDENTAL INGESTION, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY.

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  • DIRECTIONS

    FOR MILD TO MODERATE ECZEMA ONLY, APPLY AS NEEDED OR AS DIRECTED BY A PHYSICIAN.

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  • OTHER INFORMATION

    STORE AT ROOM TEMPERATURE.

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  • INACTIVE INGREDIENTS:

    WATER (AQUA), GLYCERIN, DISTEARYLDIMONIUM CHLORIDE, PANTHENOL, PETROLATUM, ISOPROPYL PALMITATE, CETYL ALCOHOL, DIMETHICONE, AVENA SATIVA (OAT) KERNEL OIL, STEARETH-20, AVENA SATIVA (OAT) KERNEL EXTRACT, BENZALKONIUM CHLORIDE, ISOCETYL ALCOHOL, CERAMIDE 3, SODIUM CHLORIDE.

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  • LABEL COPY
  • INGREDIENTS AND APPEARANCE
    ECZEMA CARE 
    colloidal oatmeal lotion
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:59779-355
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    OATMEAL (OATMEAL) OATMEAL 10 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    WATER  
    GLYCERIN  
    DISTEARYLDIMONIUM CHLORIDE  
    PANTHENOL  
    PETROLATUM  
    ISOPROPYL PALMITATE  
    CETYL ALCOHOL  
    DIMETHICONE  
    OAT KERNEL OIL  
    STEARETH-20  
    OAT  
    BENZALKONIUM CHLORIDE  
    ISOCETYL ALCOHOL  
    CERAMIDE 3  
    SODIUM CHLORIDE  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:59779-355-12 354 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part347 12/03/2012
    Labeler - CVS PHARMACY (062312574)
    Registrant - APOLLO HEALTH AND BEAUTY CARE (201901209)
    Establishment
    Name Address ID/FEI Business Operations
    APOLLO HEALTH AND BEAUTY CARE 201901209 manufacture(59779-355)
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