Label: HYLANDS NATURALS DIAPER RASH CREAM- zinc oxide cream

  • 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 June 14, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredients Purpose
    Zinc Oxide 10%.................................... skin protectant

  • PURPOSE

    Purpose
    Skin protectant

  • INDICATIONS & USAGE

    Uses
    ■ Helps treat and prevent diaper rash.
    ■ Protects chafed skin associated with diaper rash
       and helps protect from 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

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

  • DOSAGE & ADMINISTRATION

    Directions
    ■ 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 anytime when exposure to wet
      diapers may be prolonged.

  • INACTIVE INGREDIENT

    Inactive ingredients
    Organic Aloe (Aloe Barbadensis) Leaf Extract,
    Organic Beeswax, Organic Calendula Officinalis
    Flower Extract, Organic Castor (Ricinus Communis)
    Seed Oil, Organic Matricaria (Chamomilla Recutita)
    Flower Extract, Organic Sunflower (Helianthus
    Annuus) Seed Oil, Tocopherol.

  • QUESTIONS

    Questions? www.hylands.com
    or care@hylands.com

  • Package Labeling

    Hylands

    NATURALS

    • baby •

    DIAPER
    RASH
    CREAM
    Helps Soothe,
    Treat and Prevent
    Diaper Rash
    PEDIATRICIAN
    TESTED

    DO NOT USE IF TAMPER-EVIDENT SEAL
    IS BROKEN OR MISSING.

    Manufactured for:
    Hyland’s, Inc.
    Los Angeles, CA 90061
    www.hylands.com
    Certified Organic
    by Oregon Tilth

    Hylands DiapRash

    res

  • INGREDIENTS AND APPEARANCE
    HYLANDS NATURALS DIAPER RASH CREAM 
    zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54973-4101
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION10.0 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    WHITE WAX (UNII: 7G1J5DA97F)  
    CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
    CASTOR OIL (UNII: D5340Y2I9G)  
    MATRICARIA CHAMOMILLA FLOWERING TOP (UNII: 3VNC7T6Z02)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54973-4101-11 in 1 BOX12/05/2022
    185 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34712/05/2022
    Labeler - Hylands (008316655)
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