Active Ingredient

Manufacturer
Twin Med LLC
Effective date
2026-04-07
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:52:54

Label at a glance#

ProductProCure Zinc Oxide
Active ingredientZINC OXIDE
Label structure8 sections

Indications and uses

helps treat and prevent diaper rash protects chafed skin due to diaper rash and helps seal out wetness dries the ozzing and weeping of poison ivy, poison oak and posion sumac

Dosage and administration

Directions: For Diaper Rash: change wet and soiled diapers promptly cleanse the siaper area and allow to dry apply ointment liberally as often as necessary, with each diaper change, especially at bedtime or when exposure to wet diapers may be prolonged For poison ivy, oak and suman: apply as needed

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide

Purpose

OTC - PURPOSE SECTION

Skin Protectant

Uses

INDICATIONS & USAGE SECTION

  • helps treat and prevent diaper rash
  • protects chafed skin due to diaper rash and helps seal out wetness
  • dries the ozzing and weeping of poison ivy, poison oak and posion sumac

Warnings

WARNINGS SECTION

Warnings

For external use only.

When using this product

OTC - WHEN USING SECTION

When using this product do not get into eyes

Stop use and ask a doctor if

OTC - STOP USE SECTION

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

Keep out of reach of children

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

DOSAGE & ADMINISTRATION SECTION

Directions:

For Diaper Rash:

  • change wet and soiled diapers promptly
  • cleanse the siaper area and allow to dry
  • apply ointment liberally as often as necessary, with each diaper change, especially at bedtime or when exposure to wet diapers may be prolonged

For poison ivy, oak and suman: apply as needed

Inactive ingredients

INACTIVE INGREDIENT SECTION

Inactive ingredients: Ceteareth 20, Cetostearyl Alcohol, Light Mineral Oil, Petrolatum

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PCZO01 ImagePCZO01 Image

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
198911zinc oxide 20 % Topical OintmentPSN2
198911zinc oxide 0.2 MG/MG Topical OintmentSCD2
198911zinc oxide 20 % Topical OintmentSY2
198911zinc oxide 200 MG per GM Topical OintmentSY2
198911ZNO 0.2 MG/MG Topical OintmentSY2

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55681-017-01ProCure Zinc Oxide28.3 g in 1 TUBEOINTMENT28.32
55681-017-02ProCure Zinc Oxide56.6 g in 1 TUBEOINTMENT56.62
55681-017-15ProCure Zinc Oxide425 g in 1 JAROINTMENT4252

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
55681-01755681-017-01, 55681-017-02, 55681-017-15

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
ProCure Zinc OxideZINC OXIDETwin Med LLC37a30ee5-fd33-b410-e063-6294a90aef722026-04-07WarningsExact identifier
ndc (package): 55681-017-02
ndc (package): 55681-017-15
ndc (package): 55681-017-01
ndc (product): 55681-017
ndc11 (package): 55681001701
ndc11 (package): 55681001702
ndc11 (package): 55681001715
spl id: 4ee11cb5-7447-6745-e063-6394a90a5fbf
spl set id: 37a30ee5-fd33-b410-e063-6294a90aef72

Reported adverse events (FAERS/openFDA)#

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