Zinc Oxide 20%

Manufacturer: Pharmaceutica North America, Inc.
Effective date: 2025-12-29
Label type: HUMAN OTC DRUG LABEL
Version: 2
Source: monthly-update
Hydrated at: 2026-06-03 17:46:55

Label at a glance#

ProductZinc Oxide 20%

Active ingredientZINC OXIDE

Label structure8 sections

Indications and uses

Dries the oozing and weeping of poison: • Ivy • Oak • Sumac

Dosage and administration

For poison ivy, oak, and sumac: apply as needed.

Contacts and useful links#

PhonePoison Help1-800-222-1222

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide 20% w/w

Purpose

OTC - PURPOSE SECTION

Skin Protectant

Uses

INDICATIONS & USAGE SECTION

Dries the oozing and weeping of poison: • Ivy • Oak • Sumac

Warnings

WARNINGS SECTION

For External Use Only
When using this product
• Do not get into eyes
• Do not use over large areas of the body
Stop use and ask a doctor if
• The condition worsens
• Symptoms last more than 7 days or clear up and occur again within a few days
• If you are allergic to any of these ingredients
Keep out of reach of children
If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

DOSAGE & ADMINISTRATION SECTION

For poison ivy, oak, and sumac: apply as needed.

Other information

SPL UNCLASSIFIED SECTION

• Store at room temperature between 15°-30°C (59°-86°F)
• Avoid excessive heat

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Cetomacrogol 1000, Cetostearyl Alcohol, Light Mineral Oil, White Soft Paraffin (Petrolatum)

Product label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
f47a510b-6679-4664-b2d6-47b5c4afe7cc	Product name	4	20260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61c	Product name	2	20250515
0306390c-dd77-4363-afe0-63c58088b2a1	Product name	1	20220120
503ea967-4b9c-48cf-9e87-c7975295849d	Product name	2	20220120
190f2a5b-bbc8-65c7-fcb0-97891307b917	Product name	1	20140508

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
45861-082-06	GM - Gram	45861-082	b66b4c73-509d-4fdf-b360-99388e97d991	1	2025-05-14

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

Zinc Oxide 20%
ZINC OXIDE
LIGHT MINERAL OIL
CETOSTEARYL ALCOHOL
CETETH-20
PETROLATUM
ZINC CATION

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
45861-082	45861-082-06

Ingredients#

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

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

Name, UNII, Kind table
Name	UNII	Kind
LIGHT MINERAL OIL	N6K5787QVP	IACT
CETOSTEARYL ALCOHOL	2DMT128M1S	IACT
CETETH-20	I835H2IHHX	IACT
PETROLATUM	4T6H12BN9U	IACT
ZINC OXIDE	SOI2LOH54Z	ACTIM

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
471be45c-b7a7-ec9a-e063-6294a90ae569			093302ce-ecf8-4df8-b671-a9ded4ab2c21	2025-12-29	Warnings	Exact identifier spl id: 471be45c-b7a7-ec9a-e063-6294a90ae569 spl set id: 093302ce-ecf8-4df8-b671-a9ded4ab2c21

Reported adverse events (FAERS/openFDA)#

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