Label: SENSI-CARE- petrolatum, dimethicone cream

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

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated August 8, 2023

If you are a consumer or patient please visit this version.

View All Sections
  • 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 Product09/30/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalM01609/30/2020
    Labeler - Medline Industries, LP (025460908)
    Registrant - Medline Industries, LP (025460908)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!