Label: HYDRAGUARD-D- dimethicone cream

  • NDC Code(s): 53329-021-14, 53329-021-44, 53329-021-77
  • Packager: Medline Industries, LP
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated May 13, 2024

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  • Active Ingredients

    Dimethicone 12.5% w/v

  • Purpose

    Skin Protectant

  • Uses

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

    For external use only

    Do not use on

    • deep or puncture wounds
    • animal bites
    • serious burns

    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

    Keep out of reach of children.

    If swallowed, get medical help or contact Poison Control Center right away.

  • Directions

    • for skin protection
    • apply as needed
  • Other information

    Protect from freezing. Avoid excessive heat.

  • Inactive ingredients

    7-Dehydrocholestrol, Aphanizomenon Flos-Aquae (Algae) Extract, Bisabolol, Brassica Campestris (Rapeseed) Sterols, Camellia Sinensis (Green Tea) Leaf Extract, Caprylic/Capric Triglycerides, Carthamus Tinctorius (Safflower) Oleosomes, Cetylhydroxyproline Palmitamide, Cholecalciferol, Dimethicone Crosspolymer, Dimethiconol, Divinyldimethicone/Dimethicone Copolymer Emulsion, Eugenia Caryophyllus (Clove) Flower Extract, Glycerin, Hexyldecanol, Hydrolyzed Soy Protein, Jojoba Esters, Lauryl PEG-10 Tris (Trimethylsiloxy) Silylethyl Dimethicone, Manuka Honey, Olea Europaea (Olive) Oil, PEG/PPG-18/18 Dimethicone, Phenoxyethanol, Phospholipids, Phytonadione, Propanediol, Purified Water, Sodium Chloride, Stearic Acid, Tocopheryl Acetate, Yeast Ferment Extract, Zea Mays (Corn) Oil.

  • Manufacturing Information

    Manufactured for: Medline Industries, Inc.

    Three Lakes Drive, Northfield, IL 60093 USA

    Made in USA of Domestic and Imported Materials.

    www.medline.com

    1-800-MEDLINE

    REF: MSC092564

    RI18BLB

  • Package Label

    Package Label

  • INGREDIENTS AND APPEARANCE
    HYDRAGUARD-D 
    dimethicone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53329-021
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE12.5 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    CHOLECALCIFEROL (UNII: 1C6V77QF41)  
    CLOVE (UNII: K48IKT5321)  
    HYDROLYZED JOJOBA ESTERS (ACID FORM) (UNII: UDR641JW8W)  
    HONEY (UNII: Y9H1V576FH)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    PHYTONADIONE (UNII: A034SE7857)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    APHANIZOMENON FLOSAQUAE (UNII: 49VG1X560X)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    YEAST, UNSPECIFIED (UNII: 3NY3SM6B8U)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    RAPESEED STEROL (UNII: B46B6DD20U)  
    HEXYLDECANOL (UNII: 151Z7P1317)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    CORN OIL (UNII: 8470G57WFM)  
    PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)  
    7-DEHYDROCHOLESTEROL (UNII: BK1IU07GKF)  
    LEVOMENOL (UNII: 24WE03BX2T)  
    CETYLHYDROXYPROLINE PALMITAMIDE (UNII: 74ONU0S62G)  
    HYDROLYZED SOY PROTEIN (ENZYMATIC; 2000 MW) (UNII: 1394NXB9L6)  
    CARTHAMUS TINCTORIUS (SAFFLOWER) OLEOSOMES (UNII: 9S60Q72309)  
    DIMETHICONOL (100000 CST) (UNII: OSA9UP217S)  
    DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53329-021-1459 mL in 1 TUBE; Type 0: Not a Combination Product11/26/201905/31/2025
    2NDC:53329-021-44118 mL in 1 TUBE; Type 0: Not a Combination Product11/26/201906/30/2025
    3NDC:53329-021-774 mL in 1 PACKET; Type 0: Not a Combination Product11/26/201905/31/2025
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01611/26/201906/30/2025
    Labeler - Medline Industries, LP (025460908)
    Registrant - Medline Industries, LP (025460908)
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