Label: SKIN RELIEF MOISTURE LOT WITH SOOTHING OAT EXTRACTS- dimethicone liquid

  • 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 January 17, 2011

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  • ACTIVE INGREDIENT

    DIMETHICONE 1.3 PERCENT

  • PURPOSE

    SKIN PROTECTANT

  • USES

    TEMPORARILY PROTECTS AND HELPS RELIEVE CHAPPED OR CRACKED SKIN.

  • WARNINGS

    FOR EXTERNAL USE ONLY.

    WHEN USING THIS PRODUCT

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

    STOP USING THIS PRODUCT AND ASK A DOCTOR

    IF RASH OR IRRITATION DEVELOPS.  IF CONDITION WORSENS OR SYMPTOMS LAST MORE THAN SEVEN DAYS OR CLEARS UP AND RE-OCCURS 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.

  • DIRECTIONS

    ADULTS AND CHILDREN 2 YEARS AND OVER: APPLY AS NEEDED.

  • OTHER INFORMATION

    STORE AT ROOM TEMPERATURE.

  • INACTIVE INGREDIENTS

    WATER, GLYCERIN, DISTEARYLDIMONIUM CHLORIDE, PETROLATUM, ISOPROPYL PALMITATE, CETYL ALCOHOL, AVENA SATIVA (OAT) KERNEL FLOUR, SODIUM CHLORIDE, AVENA SATIVA (OAT) KERNEL OIL, STEARETH-20, BUTYROSPERMUM PARKII (SHEA BUTTER) EXTRACT, BENZYL ALCOHOL, AVENA SATIVA (OAT) KERNEL EXTRACT, METHYLPARABEN, PROPYLPARABEN.

  • PRINCIPAL DISPLAY PANEL

    IMAGE OF SKIN RELIEF MOISTURE LOTION WITH SOOTHING OAT EXTRACTS

  • INGREDIENTS AND APPEARANCE
    SKIN RELIEF MOISTURE LOT WITH SOOTHING OAT EXTRACTS 
    dimethicone liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59779-321
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE1.3 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    OATMEAL (UNII: 8PI54V663Y)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    OAT KERNEL OIL (UNII: 3UVP41R77R)  
    STEARETH-20 (UNII: L0Q8IK9E08)  
    SHEANUT OIL (UNII: O88E196QRF)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    OAT (UNII: Z6J799EAJK)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59779-321-12354 mL in 1 BOTTLE, PUMP
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34701/17/2011
    Labeler - CVS PHARMACY (062312574)
    Registrant - APOLLO HEALTH AND BEAUTY CARE (201901209)
    Establishment
    NameAddressID/FEIBusiness Operations
    APOLLO HEALTH AND BEAUTY CARE201901209manufacture
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