Label: DE LA CRUZ DIAPER RASH- allantoin, petrolatum, and zinc oxide ointment

  • NDC Code(s): 24286-1566-2, 24286-1566-3
  • Packager: DLC Laboratories, Inc.
  • 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 December 10, 2020

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredientsPurpose
    Allantoin 1%Skin protectant
    Petrolatum 45%Skin protectant
    Zinc oxide 40%Skin protectant
  • Uses

    • helps treat and prevent diaper rash
    • protects chafed skin due to diaper rash and helps seal out wetness
  • Warnings

    For external use only.

    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 the reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • change wet and soiled diapers promptly
    • cleanse the diaper area
    • allow to dry
    • apply ointment 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 room temperature
  • Inactive ingredients

    alpha-bisabolol, cholecalciferol, lanolin, lavender oil, phenoxyethanol, retinyl palmitate, tocopheryl acetate, purified water, zea mays (corn) starch

  • Questions

    1-800-858-3889

  • SPL UNCLASSIFIED SECTION

    Manufactured by:
    De La Cruz Products
    A Division of DLC Laboratories, Inc.
    Paramount, CA 90723 USA

  • PRINCIPAL DISPLAY PANEL - 96 g Tube Label

    De La Cruz®

    Baby

    Diaper Rash
    Ointment

    3 in 1
    Soothes, Heals, Protects
    MAXIMUM
    STRENGTH

    Zinc Oxide 40%
    Mild enough for everyday use
    No Artificial Fragrances or Colors,
    No Parabens or Phthalates
    Allergy Tested

    NET WT 3.4 OZ (96 g)

    PRINCIPAL DISPLAY PANEL - 96 g Tube Label
  • INGREDIENTS AND APPEARANCE
    DE LA CRUZ DIAPER RASH 
    allantoin, petrolatum, and zinc oxide ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:24286-1566
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALLANTOIN (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z) ALLANTOIN1 g  in 100 g
    PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM45 g  in 100 g
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE40 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    LANOLIN (UNII: 7EV65EAW6H)  
    WATER (UNII: 059QF0KO0R)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    CHOLECALCIFEROL (UNII: 1C6V77QF41)  
    LEVOMENOL (UNII: 24WE03BX2T)  
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:24286-1566-21 in 1 CARTON07/10/201511/12/2020
    148 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:24286-1566-396 g in 1 TUBE; Type 0: Not a Combination Product12/08/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34707/10/2015
    Labeler - DLC Laboratories, Inc. (093351930)
    Establishment
    NameAddressID/FEIBusiness Operations
    DLC Laboratories, Inc.093351930MANUFACTURE(24286-1566) , LABEL(24286-1566)