FDA.reportPublic FDA data

Z-Guard

Manufacturer
Medline Industries, LP
Effective date
2024-01-01
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
legacy-cache
Hydrated at
2026-08-01 21:12:13

Label at a glance#

ProductZ-Guard
Active ingredientPETROLATUM, ZINC OXIDE
Label structure9 sections

Indications and uses

temporarily protects and helps relieve chapped or cracked skin temporarily protects minor cuts, scrapes, and burns protects minor skin irritation associated with diaper rash and helps seal out wetness

Dosage and administration

for skin protection apply as needed for diaper rash change wet and soiled diapers promptly cleanse area and allow to dry apply as needed with each diaper change.

Storage and handling

Protect from freezing. Avoid excessive heat.

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

White Petrolatum 57%

Zinc Oxide 17%

Purpose

OTC - PURPOSE SECTION

Skin Protectant

Skin Protectant

Uses

INDICATIONS & USAGE SECTION

  • temporarily protects and helps relieve chapped or cracked skin
  • temporarily protects minor cuts, scrapes, and burns
  • protects minor skin irritation associated with diaper rash and helps seal out wetness

Warnings

WARNINGS SECTION

  • For external use only.

Do not use on

OTC - DO NOT USE SECTION

  • deep or puncture wounds
  • animal bites
  • serious burns

When using this product

OTC - WHEN USING SECTION

  • do not get into eyes

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • 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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • for skin protection
  • apply as needed
  • for diaper rash
  • change wet and soiled diapers promptly
  • cleanse area and allow to dry
  • apply as needed with each diaper change.

Other information

STORAGE AND HANDLING SECTION

  • Protect from freezing. Avoid excessive heat.

Inactive ingredients

INACTIVE INGREDIENT SECTION

7-dehydrocholesterol, Aphanizomemnon Flos-Aquae (Algae) Extract, Camellia Sinensis (Green Tea) Leaf Extract, Caprylic/Capric Triglycerides, Cocos Nucifera (Coconut) Oil, Corn Starch, Dimethicone, Ethylene Brassylate, Eugenia Caryophyllus (Clove) Flower Extract, Glycerin, Hydrolyzed Soy Protein, Isopropyl Myristate, Manuka Honey, Methyldihydrojasmonate, Olea Europaea (Olive) Fruit Oil, Paraffin Wax, Phospholipids, Tocopherol Acetate, Vanilla Planifolia Fruit Extract, Water, Yeast Ferment Extract, Zea Mays (Corn) Oil

SPL UNCLASSIFIED SECTION

Phytoplex, Medline Remedy and Medline are registered trademarks of Medline Industries, Inc., Manufactured for Medline Industries, Inc., Northfield, IL 60093 USA. Made in USA. www.medline.com 1-800-MEDLINE

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label PacketLabel Packet

Label BoxLabel BoxLabel Tube 113 gLabel Tube 113 gLabel Tube 57 gLabel Tube 57 g

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53329-137Z-GUARD (WHITE PETROLATUM,ZINC OXIDE) PASTE [MEDLINE INDUSTRIES, LP]7Legacy NDC20240130_2b70b8c7-d6d5-4bd3-e054-00144ff88e88.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
53329-137-14GM - Gram53329-137eceba76b-20b4-459e-beca-c2db39be675d12024-04-05
53329-137-44GM - Gram53329-137119ebc1f-0939-4219-bf2e-856d3a8414be12019-06-19
53329-137-96GM - Gram53329-1375eb0cff6-dbc3-4327-9660-676fc2abeb5412024-04-05

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 26 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
53329-13753329-137-14, 53329-137-44, 53329-137-16, 53329-137-96

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 24 matching rows.

Name, UNII, Kind table
NameUNIIKind
OLIVE OIL6UYK2W1W1EIACT
COCONUT OILQ9L0O73W7LIACT
PARAFFINI9O0E3H2ZEIACT
LECITHIN, SOYBEAN1DI56QDM62IACT
PETROLATUM4T6H12BN9UACTIB
ZINC OXIDESOI2LOH54ZACTIB
7-DEHYDROCHOLESTEROLBK1IU07GKFIACT
APHANIZOMENON FLOS-AQUAE49VG1X560XIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
STARCH, CORNO8232NY3SJIACT
ETHYLENE BRASSYLATE9A87HC7RODIACT
METHYL DIHYDROJASMONATE (SYNTHETIC)3GW44CIE3YIACT
CLOVEK48IKT5321IACT
GREEN TEA LEAFW2ZU1RY8B0IACT
DIMETHICONE92RU3N3Y1OIACT
GLYCERINPDC6A3C0OXIACT
HYDROLYZED SOY PROTEIN (ENZYMATIC; 2000 MW)1394NXB9L6IACT
ISOPROPYL MYRISTATE0RE8K4LNJSIACT
ALPHA-TOCOPHEROL ACETATE9E8X80D2L0IACT
WATER059QF0KO0RIACT
CORN OIL8470G57WFMIACT
YEAST3NY3SM6B8UIACT
VANILLAQ74T35078HIACT
HONEYY9H1V576FHIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
fad07aaf-6a63-f244-e053-6394a90a4c3a2b70b8c7-d6d5-4bd3-e054-00144ff88e882024-01-01WarningsExact identifier
spl id: fad07aaf-6a63-f244-e053-6394a90a4c3a
spl set id: 2b70b8c7-d6d5-4bd3-e054-00144ff88e88

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.