Label: DAILY MOISTURIZING- dimethicone lotion

  • Category: HUMAN OTC DRUG LABEL

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 November 3, 2011

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  • ACTIVE INGREDIENT

    DIMETHICONE 1.3%

  • PURPOSE

    SKIN PROTECTANT

  • USES

    TEMPORARILY PROTECTS AND HELPS RELIEVE CHAFED, CHAPPED OR CRACKED SKIN.
  • WARNINGS

    FOR EXTERNAL USE ONLY.

    DO NOT USE

    • ON DEEP PUNCTURE WOUNDS
    • ON ANIMAL BITES
    • ON SERIOUS BURNS

    WHEN USING THIS PRODUCT

    DO NOT GET INTO EYES.  SHOULD THIS OCCUR, RINSE WITH WATER.

    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.

    KEEP OUT OF REACH OF CHILDREN

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

  • DIRECTIONS

    APPLY AS NEEDED.

  • INACTIVE INGREDIENTS

    WATER, GLYCERIN, DISTEARYLDIMONIUM CHLORIDE, PETROLATUM, ISOPROPYL MYRISTATE, CETYL ALCOHOL, AVENA SATIVA (OAT) KERNEL FLOUR, BENZYL ALCOHOL, SODIUM CHLORIDE, DMDM HYDANTOIN, METHYLPARABEN, PROPYLPARABEN.

  • FRONT AND BACK LABELS

    image of label

  • INGREDIENTS AND APPEARANCE
    DAILY MOISTURIZING 
    dimethicone lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59779-324
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE1.3 g  in 100 g
    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)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59779-324-0371 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34711/03/2011
    Labeler - CVS PHARMACY (062312574)
    Registrant - APOLLO HEALTH AND BEAUTY CARE (201901209)
    Establishment
    NameAddressID/FEIBusiness Operations
    APOLLO HEALTH AND BEAUTY CARE201901209manufacture
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