Label: MEDLINE- zinc oxide spray

  • NDC Code(s): 53329-768-55
  • Packager: Medline Industries, LP
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 24, 2024

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  • Active ingredient

    Zinc oxide 25% w/w

  • Purpose

    Skin Protectant

  • Uses

    • helps treat and prevent diaper rash. Protects minor skin irritation associated with diaper rash and helps seal out wetness
  • Warnings

    For external use only

    Do not use on

    • deep or puncture wounds
    • animal bites
    • serious burns

    When using this product

    • do not get into eyes

    Stop use and ask a doctor

    • condition worsens
    • symptoms last for 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 right away.

    Contents under pressure.

    Do not puncture or incinerate. Do not store at temperatures above 120°F.

  • Directions

    • shake well before using
    • for skin protection
    • apply as needed
    • for diaper rash
    • change wet and soiled diapers promptly, cleanse the diaper area, and allow to dry. Apply product liberally as often as necessary, with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged
  • Other information

    • Protect from freezing, avoid excessive heat
    • Nonflammable
  • Inactive ingredients

    aleurites moluccanus (kukui) seed oil, allantoin, aphanizomenon flos aquae extract, astrocaryum murumuru seed butter, butylene glycol, camellia sinensis (green tea) leaf extract, caprylic/capric triglyceride, cetyl alcohol, 7-dehydrocholesterol, dehydroxanthan gum, dicaprylyl carbonate, diisopropyl adipate, dimethicone, ethylhexylglycerin, eugenia caryophyllus (clove) flower extract, gelidiella acerosa (algae) extract, glycerin, hydrolyzed soy protein, hypnea musciformis (algae) extract, magnesium sulfate, PEG-30 dipolyhydroxystearate, phenoxyethanol, phospholipids, polyamide-8, polyglyceryl-3 diisostearate, polyhydroxystearic acid, propanediol, propylene glycol dicaprylate/dicaprate, sorbitan sesquioleate, tetrafluoropropene, tocopheryl acetate, water, yeast ferment extract, zea mays (corn) oil, zeolite

  • Manufacturing information

    www.medline.com
    ©2023 Medline and Medline Remedy are registered trademarks of Medline Industries, LP.

    Made in the USA of foreign and domestic materials.
    Manufactured for Medline Industries, LP, Three Lakes Drive, Northfield, IL 60093 USA.

    1-800-MEDLINE

    V1 RG23FZS

  • Package Label

    label

  • INGREDIENTS AND APPEARANCE
    MEDLINE 
    zinc oxide spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53329-768
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE250 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    ALLANTOIN (UNII: 344S277G0Z)  
    APHANIZOMENON FLOSAQUAE (UNII: 49VG1X560X)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    DIISOPROPYL ADIPATE (UNII: P7E6YFV72X)  
    WATER (UNII: 059QF0KO0R)  
    ZEA MAYS (CORN) OIL (UNII: 8470G57WFM)  
    KUKUI NUT OIL (UNII: TP11QR7B8R)  
    GELIDIELLA ACEROSA (UNII: T91K54D6M1)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POLYAMIDE-8 (4500 MW) (UNII: 77723GV81A)  
    POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    1,3,3,3-TETRAFLUOROPROPENE, (1Z)- (UNII: XXV68QSS1E)  
    DEHYDROXANTHAN GUM (UNII: 63ZP7I1BQO)  
    EUGENIA CARYOPHYLLUS (CLOVE) FLOWER EXTRACT (UNII: K48IKT5321)  
    OMEGA-3 FATTY ACIDS (UNII: 71M78END5S)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    PROPYLENE GLYCOL DICAPRYLATE/DICAPRATE (UNII: O4446S9CRA)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    YEAST EXTRACT (UNII: 3NY3SM6B8U)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    MAGNESIUM SULFATE (UNII: DE08037SAB)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)  
    SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    HYDROLYZED SOY PROTEIN (ENZYMATIC; 2000 MW) (UNII: 1394NXB9L6)  
    HYPNEA MUSCIFORMIS EXTRACT (UNII: W6FF9R1FJV)  
    CAMELLIA SINENSIS LEAF (UNII: W2ZU1RY8B0)  
    7-DEHYDROCHOLESTEROL (UNII: BK1IU07GKF)  
    ASTROCARYUM MURUMURU SEED BUTTER (UNII: 12V64UPU6R)  
    PEG-30 DIPOLYHYDROXYSTEARATE (UNII: 9713Q0S7FO)  
    ZEOLITE A (UNII: Y3NG9WF08W)  
    CAPRYLIC/CAPRIC TRIGLYCERIDE (UNII: C9H2L21V7U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53329-768-5559 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product12/01/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01612/01/2023
    Labeler - Medline Industries, LP (025460908)
    Registrant - Medline Industries, LP (025460908)
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