Label: MEDLINE- dimethicone cream

  • NDC Code(s): 53329-154-04, 53329-154-13, 53329-154-23, 53329-154-84
  • Packager: Medline Industries, LP
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 28, 2023

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  • Active ingredient

    Dimethicone 1.5% w/v

  • Purpose

    Skin protectant

  • Uses

    • helps prevent and temporarily protects and helps relieve chapped or cracked skin
    • helps prevent and protect from the drying effects of wind and cold weather
  • Warnings

    For external use only

    Do not use

    • deep or puncture wounds
    • animal bites
    • serious burns

    When using this product

    • do not get into eyes

    Stope 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 right away.

  • Directions

    • apply one ounce to full body per application, twice daily
    • apply especially right after bath or shower for best effect
  • Other information

    • protect from freezing
    • avoid excessive heat
    • not made with Natural Rubber Latex
  • Inactive ingredients


    acetyl cysteine, aloe barbadensis leaf juice, arginine, ascorbic acid, ascorbyl palmitate, canola oil, cetyl alcohol, cholecalciferol, citric acid, dimethyl sulfone, ethylhexylglycerin, fragrance, glycerin, glyceryl stearate SE, glycine, hydrated silica, niacinamide, olea europaea (olive) fruit oil, olea europaea leaf extract, olea europaea leaf powder, oleuropein, PEG-8, PEG-100 stearate, phenoxyethanol, proline, propanediol, pyridoxine HCL, retinyl palmitate, stearic acid, stearyl alcohol, taurine, tetrasodium glutamate diacetate, tocopherol, water, zea mays (corn) oil

  • Manufacturing Information

    Manufactured for:

    Medline Industries, LP

    Three Lakes Drive, Northfield, IL 60093 USA

    Made in USA with domestic and foreign materials

    www.medline.com

    1-800-MEDLINE (633-5463)

    REF: MSC0924402

    V1 RL22WAR

  • Package Label

    Label V1 RL22WAR

  • INGREDIENTS AND APPEARANCE
    MEDLINE 
    dimethicone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53329-154
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE15 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY)  
    ASCORBIC ACID (UNII: PQ6CK8PD0R)  
    PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV)  
    WATER (UNII: 059QF0KO0R)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    CORN OIL (UNII: 8470G57WFM)  
    .ALPHA.-TOCOPHEROL, DL- (UNII: 7QWA1RIO01)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    OLEUROPEIN (UNII: 2O4553545L)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    CANOLA OIL (UNII: 331KBJ17RK)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    CHOLECALCIFEROL (UNII: 1C6V77QF41)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    ASCORBYL PALMITATE (UNII: QN83US2B0N)  
    DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ACETYLCYSTEINE (UNII: WYQ7N0BPYC)  
    TAURINE (UNII: 1EQV5MLY3D)  
    PROLINE (UNII: 9DLQ4CIU6V)  
    ARGININE (UNII: 94ZLA3W45F)  
    GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    GLYCINE (UNII: TE7660XO1C)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53329-154-1359 mL in 1 TUBE; Type 0: Not a Combination Product09/01/2023
    2NDC:53329-154-04118 mL in 1 TUBE; Type 0: Not a Combination Product11/01/2023
    3NDC:53329-154-23946 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product11/01/2023
    4NDC:53329-154-841000 mL in 1 BAG; Type 0: Not a Combination Product11/01/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01609/01/2023
    Labeler - Medline Industries, LP (025460908)
    Registrant - Medline Industries, LP (025460908)
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