Label: EVERYDAY DIAPER RASH CREAM- zinc oxide cream

  • NDC Code(s): 69366-507-17, 69366-507-33
  • Packager: The Honest Company, Inc
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 5, 2023

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  • Drug Facts

  • ACTIVE INGREDIENT

    Active ingredient

    Zinc Oxide 14%

  • PURPOSE

    Purpose

    Skin protectant

  • INDICATIONS & USAGE

    Uses:

    • Helps treat and prevent diaper rash
    • Protects chafed skin due to diaper rash and helps seal out wetness.
  • WARNINGS

    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 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 immediately.

  • DOSAGE & ADMINISTRATION

    Directions:

    • Change soiled and wet diapers promptly, cleanse the diaper area, and allow to dry
    • Apply diaper rash cream liberally as often as necessary to help prevent or treat irritation, with each diaper change, and especially at bedtime or anytime when exposure to wet diapers may be prolonged.

  • SPL UNCLASSIFIED SECTION

    Other information:
    • Will stain clothing • Store at room temperature.

  • INACTIVE INGREDIENT

    Inactive ingredients:
    Helianthus Annuus (Sunflower) Seed Oil, Bis-Diglyceryl Polyacyladipate-2, Polyhydroxystearic Acid,
    Glyceryl Behenate, Helianthus Annuus (Sunflower) Seed Wax, Solanum Tuberosum (Potato) Starch,
    Caprylic/Capric Triglyceride, Linoleic Acid, Phytosterols, Phospholipids, Bisabolol, Zinc Carbonate, Water
    (Aqua/Eau), Stearyl Glycyrrhetinate, Tocopherol

  • PRINCIPAL DISPLAY PANEL

    HONEST ®

    EVERYDAY DIAPER RASH CREAM

    FRAGRANCE FREE

    Zinc Oxide

    Skin Protectant +

    Soothing Phyto-Blend™

    Net Wt. 2.5 oz. (70.8 g)

    © 2022 Distributed by

    The Honest Company, Inc.,

    12130 Millennium Dr #500

    Los Angeles, CA 90094

    HONEST.COM • 888-862-8818

    carton 2.5 oz

  • PRINCIPAL DISPLAY PANEL

    Tube 6 oz

  • INGREDIENTS AND APPEARANCE
    EVERYDAY DIAPER RASH CREAM 
    zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69366-507
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE14 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    TOCOPHEROL (UNII: R0ZB2556P8)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    ZINC CARBONATE (UNII: EQR32Y7H0M)  
    STEARYL GLYCYRRHETINATE (UNII: 3YYE6VJS0P)  
    LEVOMENOL (UNII: 24WE03BX2T)  
    BIS-DIGLYCERYL POLYACYLADIPATE-2 (UNII: 6L246LAM9T)  
    HELIANTHUS ANNUUS SEED WAX (UNII: 42DG15CHXV)  
    STARCH, POTATO (UNII: 8I089SAH3T)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERYL DIBEHENATE (UNII: R8WTH25YS2)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    LINOLEIC ACID (UNII: 9KJL21T0QJ)  
    SOY STEROL (UNII: PL360EPO9J)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69366-507-171 in 1 CARTON04/17/2023
    170.8 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:69366-507-33170 g in 1 TUBE; Type 0: Not a Combination Product01/21/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01604/17/2023
    Labeler - The Honest Company, Inc (969962757)
    Establishment
    NameAddressID/FEIBusiness Operations
    Levlad076245109manufacture(69366-507)
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