Label: MEDLINE- dimethicone cream

  • NDC Code(s): 53329-159-04, 53329-159-13, 53329-159-77, 53329-159-96
  • Packager: Medline Industries, LP
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated May 1, 2024

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  • Active ingredient

    Dimethicone 12.5% w/v

  • Purpose

    Skin protectant

  • Uses

    • helps treat and prevent diaper rash
    • protects minor skin irritation with diaper rash and helps seal out wetness
  • 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 a Poison Control Center right away.

  • Directions

    • change wet and soiled diapers promptly, cleans the diaper area and allow to dry
    • apply cream liberally as often as necessary with each diaper change esspecially at bedtime or anytime when exposure to wet diapers may be prolonged
  • 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, LP

    Three Lakes Drive, Northfield, IL 60093 USA

    Made in USA of domestic and imported materials

    www.medline.com

    1-800-MEDLINE (633-5463)

    REF: MSC092564

    V3 RJ23BLB

  • Package Label

    Label V3 RJ23BLB

  • INGREDIENTS AND APPEARANCE
    MEDLINE 
    dimethicone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53329-159
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE125 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    DIMETHICONOL (2000 CST) (UNII: T74O12AN6Y)  
    JOJOBA OIL, RANDOMIZED (UNII: 7F0EV20QYL)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    CHOLECALCIFEROL (UNII: 1C6V77QF41)  
    CLOVE (UNII: K48IKT5321)  
    HEXYLDECANOL (UNII: 151Z7P1317)  
    HYDROLYZED SOY PROTEIN (ENZYMATIC; 2000 MW) (UNII: 1394NXB9L6)  
    APHANIZOMENON FLOSAQUAE (UNII: 49VG1X560X)  
    CARTHAMUS TINCTORIUS (SAFFLOWER) OLEOSOMES (UNII: 9S60Q72309)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    HONEY (UNII: Y9H1V576FH)  
    CETYLHYDROXYPROLINE PALMITAMIDE (UNII: 74ONU0S62G)  
    PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)  
    PHYTONADIONE (UNII: A034SE7857)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    YEAST, UNSPECIFIED (UNII: 3NY3SM6B8U)  
    CORN OIL (UNII: 8470G57WFM)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    OMEGA-3 FATTY ACIDS (UNII: 71M78END5S)  
    LEVOMENOL (UNII: 24WE03BX2T)  
    RAPESEED STEROL (UNII: B46B6DD20U)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    7-DEHYDROCHOLESTEROL (UNII: BK1IU07GKF)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53329-159-1359 mL in 1 TUBE; Type 0: Not a Combination Product05/01/2023
    2NDC:53329-159-04118 mL in 1 TUBE; Type 0: Not a Combination Product04/01/2023
    3NDC:53329-159-774 mL in 1 PACKET; Type 0: Not a Combination Product05/01/2024
    4NDC:53329-159-96144 in 1 BOX05/01/2024
    44 mL in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01604/01/2023
    Labeler - Medline Industries, LP (025460908)
    Registrant - Medline Industries, LP (025460908)
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