Label: 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 November 30, 2022

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  • ACTIVE INGREDIENT

    Active ingredient Purpose
    Zinc Oxide 15% ..................................... Skin Protectant

  • PURPOSE

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

  • 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.

  • INDICATIONS & USAGE

    Stop use and ask adoctor if

    • condition worsens

    • symptoms last more than 7 days or clear up and occur again within a few days.

  • WARNINGS

    WarningsFor external use only.

    When using this product • Avoid contact with eyes

  • 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 Helianthus Annuus (Sunflower) Seed Oil, Beeswax (Cera Alba), Polyhydroxystearic Acid, Butyrospermum Parkii (Shea Butter), Calophyllum Tacamahaca (Tamanu) Seed Oil, Olea Europaea (Olive) Fruit Oil, Cocos Nucifera (Coconut) Oil, Honey, Chamomilla Recutita (Matricaria) Flower Extract, Citrus Aurantium Amara (Bitter Orange) Flower Extract, Citrus Aurantium Dulcis (Orange) Peel Extract, Citrus Limon (Lemon) Peel Extract, Salvia Officinalis (Sage) Leaf Extract, Thymus Vulgaris (Thyme) Flower/Leaf Extract,Tocopherol, Squalene, Sterols, Monoglycerides.

  • PRINCIPAL DISPLAY PANEL

    Diaper Rash Cream

    3.3 FL OZ / 98mL

    Diaper Rash Cream

  • INGREDIENTS AND APPEARANCE
    DIAPER RASH CREAM 
    zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72381-101
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE15 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    CALOPHYLLUM TACAMAHACA SEED OIL (UNII: 05G85L61OE)  
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    HONEY (UNII: Y9H1V576FH)  
    LEMON PEEL (UNII: 72O054U628)  
    SAGE (UNII: 065C5D077J)  
    SQUALENE (UNII: 7QWM220FJH)  
    WHITE WAX (UNII: 7G1J5DA97F)  
    CHAMOMILE (UNII: FGL3685T2X)  
    CITRUS AURANTIUM FLOWER (UNII: O730ZX2Z83)  
    CITRUS SINENSIS FLOWER (UNII: H02N5LQ5F6)  
    THYME (UNII: CW657OBU4N)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72381-101-0198 mL in 1 TUBE; Type 0: Not a Combination Product06/07/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34706/07/2018
    Labeler - Hamilton Therapeutics, Inc (099419360)
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