Label: SENSI-CARE- petrolatum, dimethicone cream

  • NDC Code(s): 53329-770-79
  • Packager: Medline Industries, LP
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated July 2, 2024

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  • Active ingredients

    Dimethicone 1% w/w

    White petrolatum 30% w/w

  • Purpose

    Skin protectant

  • Uses

    • temporarily protects minor cuts, scrapes, burns
    • temporarily protects and helps relieve chapped or cracked skin and lips
    • helps treat and prevent diaper rash
    • protects minor skin irritation associated 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 in eyes

    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.

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

  • Directions

    for skin protection:

    • apply as needed

    for diaper rash:

    • change wet and soiled diapers promptly, cleanse the diaper area, and allow to dry
    • apply cream liberally, as often as necessary, with each diaper change, especially at bedtime or any time when exposure to wet diaper may be prolonged
  • Inactive ingredients

    carbomer, cetyl alcohol, diazolidinyl urea, glycerin, laureth-23, magnesium, magnesium aluminum silicate, magnesium chloride, methylchloroisothiazolinone, methylisothiazolinone, nitrate, propylene glycol diethylhexanoate, pvp/hexadecene copolymer, sodium hydroxide, steareth-2, water

  • Manufacturing Information

    Manufactured for: Medline Industries, LP

    Three Lakes Drive, Northfield, IL 60093 USA

    Made in USA of foreign and domestic materials

    www.medline.com

    1-800-MEDLINE

    REF: 324403

    V1 RE21GSG

  • Package Label

    Package Label

  • INGREDIENTS AND APPEARANCE
    SENSI-CARE 
    petrolatum, dimethicone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53329-770
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE1 g  in 100 g
    PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM30 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    HEXADECENE (MIXED ISOMERS) (UNII: 38H8547VP0)  
    STEARETH-2 (UNII: V56DFE46J5)  
    WATER (UNII: 059QF0KO0R)  
    MAGNESIUM (UNII: I38ZP9992A)  
    MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)  
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    NITRATE ION (UNII: T93E9Y2844)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    LAURETH-23 (UNII: N72LMW566G)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    PROPYLENE GLYCOL DIETHYLHEXANOATE (UNII: 8D8I9Z0F1Z)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53329-770-7985 g in 1 TUBE; Type 0: Not a Combination Product09/30/202004/30/2025
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01609/30/202004/30/2025
    Labeler - Medline Industries, LP (025460908)
    Registrant - Medline Industries, LP (025460908)
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