Label: SENSI-CARE- petrolatum, zinc oxide cream

  • NDC Code(s): 53329-771-44
  • Packager: Medline Industries, LP
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated July 2, 2024

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  • Active ingredient

    White petrolatum 49% w/w

    Zinc oxide 15% w/w

  • Purpose

    Skin protectant

  • Uses

    • 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 adn 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 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 contact a Poison Control Center right away.

  • Directions

    for skin protection:

    • apply as needed

    for diaper rash:

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

    • store at 15°C-30°C (59°F-86°F)
  • Inactive ingredients

    carboxymethylcellulose sodium, cetyl dimethicone copolyol, glycerin, hexyl laurate, phenoxyethanol, polyglyceryl-4 isostearate, stearic acid, water

  • Manufacturing Information

    Manufactured for: Medline Industries, LP

    Three Lakes Drive, Northfield, IL 60093 USA

    Made in USA with foreign and domestic materials

    www.medline.com

    1-800-MEDLINE

    REF: 325614

    V1 RE21AXQ

  • Package Label

    Package Label

  • INGREDIENTS AND APPEARANCE
    SENSI-CARE 
    petrolatum, zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53329-771
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE15 g  in 100 g
    PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM49 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53329-771-44113 g in 1 TUBE; Type 0: Not a Combination Product09/30/202010/31/2025
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01609/30/202010/31/2025
    Labeler - Medline Industries, LP (025460908)
    Registrant - Medline Industries, LP (025460908)
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