Label: PRESTO- 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 December 15, 2017

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  • ACTIVE INGREDIENT

     Active ingredient Purpose
    Zinc Oxide 5.0 % Skin Protectant

  • INACTIVE INGREDIENT

    Purified Water, cyclotetrasiloxane , Isopropyl palmitate,
    Ethylhexyl palmitate, Glycerin, Cyclopentasiloxane,
    Polyglyceryl-4 Isostearate, Cetyl PEG/PPG-10/1
    Dimethicone, Hexyl Laurate, Dimethicone, Tocopherol
    (Vitamin E), Zea Mays Oil, Retinyl palmitate(Vitamin A),
    Cholecalciferol (Vitamin D), Beeswax, Hydrogenated Castor
    Oil, Sodium Chloride, DMDM Hydantoin.

  • KEEP OUT OF REACH OF CHILDREN

    If swallowed, get medical help or contact a Poison Control Center right away.

  • INDICATIONS & USAGE

    Helps treat and prevent diaper rash.

  • WARNINGS

    For external use only. When using this product avoid contact with 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.

  • DOSAGE & ADMINISTRATION

    Change wet and soiled diapers promptly. Cleanse the affected area, and allow to dry. Apply cream liberally as often as necessary, with each change, especially at bedtime or anytime when exposure to wet diapers may be prolonged.

  • PURPOSE

    • Helps treat and prevent diaper rash.
    • Protects chafed skin associated with diaper rash and helps protect from wetness.

  • PRESTO

    Distributed by:
    Drylock Technologies Ltd.
    3921 North Hastings Way
    Eau Claire, WI 54703
    1-877-202-4652
    questions@prestoabsorbent.com
    © 2017 Drylock Technologies Ltd.
    Made in USA with domestic and imported materials.

    Label Image
  • INGREDIENTS AND APPEARANCE
    PRESTO 
    zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53113-162
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE5 g  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    APIS CERANA WORKER SECRETION (UNII: PRG8653U8K)  
    CETYL PEG/PPG-10/1 DIMETHICONE (HLB 1.5) (UNII: V2W71V8T0X)  
    CHOLECALCIFEROL (UNII: 1C6V77QF41)  
    CORN OIL (UNII: 8470G57WFM)  
    CYCLOMETHICONE 4 (UNII: CZ227117JE)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HEXYL LAURATE (UNII: 4CG9F9W01Q)  
    ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53113-162-06177 mL in 1 BOTTLE; Type 0: Not a Combination Product06/01/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34706/01/2017
    Labeler - GADAL Laboratories, Inc (841305639)
    Establishment
    NameAddressID/FEIBusiness Operations
    GADAL Laboratories, Inc841305639MANUFACTURE(53113-162)
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