FDA.reportPublic FDA data

Zinc Oxide

Manufacturer
Geri-Gentle Corporation
Effective date
2025-09-29
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 01:15:11

Label at a glance#

ProductZinc Oxide
Active ingredientZINC OXIDE
Label structure9 sections

Indications and uses

helps treat and prevent diaper rash dries the oozing and weeping of: poison ivy poison oak poison sumac

Dosage and administration

change wet and soiled diaper promptly cleanse the diaper area and allow to dry apply as needed

Storage and handling

store at 59°-86°F (15°-30°C) avoid excessive heat

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide (20%w/w)

Purpose

OTC - PURPOSE SECTION

Skin Protectant

Uses

INDICATIONS & USAGE SECTION

  • helps treat and prevent diaper rash
  • dries the oozing and weeping of:
    • poison ivy
    • poison oak
    • poison sumac

Warnings

WARNINGS SECTION

For external use only

When using this product

OTC - WHEN USING SECTION

  • do not get into eyes
  • do not use over large area of the body

Stop Use and ask a doctor if

OTC - STOP USE SECTION

  • condition worsens
  • symptoms last more than 7 days or clear up and occur again in a few days
  • if you are allergic to any of these ingredients

Do not use on

OTC - DO NOT USE SECTION

  • deep puncture wounds
  • animal bites
  • serious burns

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

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

Directions for Diaper Rash

DOSAGE & ADMINISTRATION SECTION

  • change wet and soiled diaper promptly
  • cleanse the diaper area and allow to dry
  • apply as needed

Other information

STORAGE AND HANDLING SECTION

  • store at 59°-86°F (15°-30°C)
  • avoid excessive heat

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Cetostearyl Alcohol, Cetomacrogol 1000, Lanolin, Light Liquid Paraffin, White Soft Paraffin

PRINCIPAL DISPLAY PANEL - 28.4 g Tube Box

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principal Display and Drug Fact PanelPrincipal Display and Drug Fact Panel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
198911zinc oxide 20 % Topical OintmentPSN6
198911zinc oxide 0.2 MG/MG Topical OintmentSCD6
198911zinc oxide 20 % Topical OintmentSY6
198911zinc oxide 200 MG per GM Topical OintmentSY6
198911ZNO 0.2 MG/MG Topical OintmentSY6

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69771-109-382025-01-06C16284748780-19d75b9cf-f9bc-f424-e053-dadaa90a57ceZinc Oxide
69771-109-392025-01-06C16284748780-19d75b9cf-f9bc-f424-e053-dadaa90a57ceZinc Oxide
69771-109-382023-01-30C16284748780-19d75b9cf-f9bc-f424-e053-dadaa90a57ceZinc Oxide
69771-109-392023-01-30C16284748780-19d75b9cf-f9bc-f424-e053-dadaa90a57ceZinc Oxide
69771-109-382020-02-04C16284748780-19d75b9cf-f9bc-f424-e053-dadaa90a57ceZinc Oxide
69771-109-392020-02-04C16284748780-19d75b9cf-f9bc-f424-e053-dadaa90a57ceZinc Oxide
69771-109-382020-01-31C16284748780-19d75b9cf-f9bc-f424-e053-dadaa90a57ceZinc Oxide
69771-109-392020-01-31C16284748780-19d75b9cf-f9bc-f424-e053-dadaa90a57ceZinc Oxide

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69771-109-38Zinc Oxide1 in 1 BOXOINTMENT16
69771-109-38Zinc Oxide28.4 g in 1 TUBEOINTMENT28.46
69771-109-39Zinc Oxide1 in 1 BOXOINTMENT16
69771-109-39Zinc Oxide56.8 g in 1 TUBEOINTMENT56.86

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69771-10969771-109-38, 69771-109-39

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
LANOLIN7EV65EAW6HIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
CETETH-20I835H2IHHXIACT
LIGHT MINERAL OILN6K5787QVPIACT
PETROLATUM4T6H12BN9UIACT
ZINC OXIDESOI2LOH54ZACTIB

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
Zinc OxideZINC OXIDEGeri-Gentle Corporationf5cfab62-8aab-4109-b15b-4fe380f7cb9e2025-09-29WarningsExact identifier
ndc (package): 69771-109-38
ndc (package): 69771-109-39
ndc (product): 69771-109
ndc11 (package): 69771010938
ndc11 (package): 69771010939
spl id: 3ff42319-2fba-acb9-e063-6294a90a4129
spl set id: f5cfab62-8aab-4109-b15b-4fe380f7cb9e

Reported adverse events (FAERS/openFDA)#

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