Dynarex Zinc Oxide

Manufacturer
Dynarex Corporation
Effective date
2024-11-20
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
legacy-cache
Hydrated at
2026-08-01 20:48:56

Label at a glance#

ProductDynarex Zinc Oxide
Active ingredientZINC OXIDE
Label structure10 sections

Indications and uses

Helps treat chafed skin associated with diaper rash Dries the oozing and weeping of poison: ■ ivy ■ oak ■ sumac

Dosage and administration

For diaper rash: Change wet and soiled diapers promptly, cleanse the diaper area, and allow to dry. Apply ointment liberally as often as necessary with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged. For poison ivy, oak, and sumac: Apply as needed.

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide 25%

Purpose

OTC - PURPOSE SECTION

Skin Protectant

Uses

INDICATIONS & USAGE SECTION

  • Helps treat chafed skin associated with diaper rash
  • Dries the oozing and weeping of poison: ■ ivy ■ oak ■ sumac

Warnings

WARNINGS SECTION

For External Use Only

When using this product

OTC - WHEN USING SECTION

  • Avoid contact with eyes

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 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 (1-800-222-1222) right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • For diaper rash: Change wet and soiled diapers promptly, cleanse the diaper area, and allow to dry. Apply ointment liberally as often as necessary with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged.
  • For poison ivy, oak, and sumac: Apply as needed.

Other Information

OTHER SAFETY INFORMATION

  • Store at room temperature between 15º-30°C (59º-86°F)
  • Avoid excessive heat
  • Tamper evident. Do not use if seal is damaged.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

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

1190 Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

1190 BX MASTER1190 BX MASTER1190 Label

1191 Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

1191 BX MASTER1191 BX MASTER1191 Label

1192 Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

1192 IN MASTER1192 IN MASTER1192 Label

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67777-119DYNAREX ZINC OXIDE (ZINC OXIDE OINTMENT) OINTMENT [DYNAREX CORPORATION]7Legacy NDC20241122_686729af-f96e-a860-e053-2a91aa0af575.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67777-119-10GM - Gram67777-119ce5be7f6-daa5-4525-832c-e4f1ba8257e512023-02-06
67777-119-12GM - Gram67777-11923991df9-14c7-420c-aada-0f0eb571cee412023-02-06

Products#

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

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NDC Codes#

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

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
3ab1fa5c-5cbc-259f-e063-6294a90acae6686729af-f96e-a860-e053-2a91aa0af5752025-07-24WarningsExact identifier
spl set id: 686729af-f96e-a860-e053-2a91aa0af575

Reported adverse events (FAERS/openFDA)#

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