Label: MEDLINE REMEDY PHYTOPLEX SKIN REPAIR- dimeticone cream

  • NDC Code(s): 53329-995-04, 53329-995-13, 53329-995-23, 53329-995-84
  • Packager: Medline Industries, LP
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated May 13, 2024

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  • Active ingredient

    Dimethicone 5%

  • Purpose

    Skin protectant

  • Uses

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

    • For external use only

    Do not use

    • on deep or puncture wounds
    • on animal bites
    • on serious burns

    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 a Poison Control Center right away.

  • Directions

    • apply as needed
  • Other information

    Protect from freezing. Avoid excessive heat.

  • Inactive ingredients

    aphanizomenon flos-aquae (algae) extract, bisabolol, brassica campestris (rapeseed) sterols, camellia sinensis (green tea) leaf extract, caprylic/capric triglycerides, caprylyl glycol, carthamus tinctorius (safflower) oleosomes, cetyl alcohol, cetylhydroxyproline palmitamide, cholecalciferol, cocos nucifera (coconut oil), 7-dehydrocholesterol, eugenia caryophyllus (clove) flower extract, glycerin, glyceryl stearate, glycol distearate, 1,2-hexanediol, hexyldecanol, hydrolyzed soy protein, hydroyacetophenone, jojoba esters, manuka honey, olea europaea (olive oil), peg 100 stearate, phospholipids, phytonadione, propanediol, stearic acid, tocopherol acetate, water, yeast ferment extract, zea mays (corn) oil

  • Manufacturing Information

    Phytoplex, Medline Remedy, and Medline are registered trademarks of Medline Industries Inc.

    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

    RK20BLB

  • Package Labels

    Package Label

  • INGREDIENTS AND APPEARANCE
    MEDLINE REMEDY PHYTOPLEX SKIN REPAIR 
    dimeticone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53329-995
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE5 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    HEXANEDIOL (UNII: ZIA319275I)  
    HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)  
    GLYCOL DISTEARATE (UNII: 13W7MDN21W)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CARTHAMUS TINCTORIUS (SAFFLOWER) OLEOSOMES (UNII: 9S60Q72309)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    YEAST, UNSPECIFIED (UNII: 3NY3SM6B8U)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    CORN OIL (UNII: 8470G57WFM)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    WATER (UNII: 059QF0KO0R)  
    APHANIZOMENON FLOSAQUAE (UNII: 49VG1X560X)  
    LEVOMENOL (UNII: 24WE03BX2T)  
    HEXYLDECANOL (UNII: 151Z7P1317)  
    HYDROLYZED SOY PROTEIN (ENZYMATIC; 2000 MW) (UNII: 1394NXB9L6)  
    RAPESEED STEROL (UNII: B46B6DD20U)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    PHYTONADIONE (UNII: A034SE7857)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    CETYLHYDROXYPROLINE PALMITAMIDE (UNII: 74ONU0S62G)  
    CLOVE (UNII: K48IKT5321)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    7-DEHYDROCHOLESTEROL (UNII: BK1IU07GKF)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    JOJOBA OIL (UNII: 724GKU717M)  
    HONEY (UNII: Y9H1V576FH)  
    CHOLECALCIFEROL (UNII: 1C6V77QF41)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53329-995-04118 mL in 1 TUBE; Type 0: Not a Combination Product11/01/201906/30/2025
    2NDC:53329-995-1359 mL in 1 TUBE; Type 0: Not a Combination Product11/01/201903/31/2025
    3NDC:53329-995-23946 mL in 1 TUBE; Type 0: Not a Combination Product11/01/201906/30/2025
    4NDC:53329-995-841000 mL in 1 BAG; Type 0: Not a Combination Product11/01/201906/30/2025
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01611/01/201906/30/2025
    Labeler - Medline Industries, LP (025460908)
    Registrant - Medline Industries, LP (025460908)
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