FDA.reportPublic FDA data

Rugby Zinc Oxide Ointment 20%

Manufacturer
Rugby Laboratories | ANICARE PHARMACEUTICALS PRIVATE LIMITED
Effective date
2024-12-18
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 20:45:09

Label at a glance#

ProductRugby Zinc Oxide
Active ingredientZINC OXIDE
Label structure9 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.

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide 20%

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

OTC - WHEN USING SECTION

• Avoid contact with eyes

• Do not use over large areas 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 within a few days

• If you are allergic to any of these ingredients

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

Other Information

OTHER SAFETY INFORMATION

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

• Avoid excessive heat

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Cetomacrogol 1000, Cetostearyl Alcohol, Light liquid paraffin (Mineral Oil), Petrolatum

Questions and Comments?

OTC - QUESTIONS SECTION

Toll free 1-866-326-1313

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabel

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0536-1393-982025-08-12C16284748780-13b156c62-3156-fb37-e063-e6dba90a4e07Rugby Zinc Oxide Ointment 20%
0536-1393-982025-07-29C16284748780-13b156c62-3156-fb37-e063-e6dba90a4e07Rugby Zinc Oxide Ointment 20%

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0536-1393RUGBY ZINC OXIDE (ZINC OXIDE 20%) OINTMENT [RUGBY LABORATORIES]3Unmatched20241220_00c4c849-7db9-8264-e063-6394a90ab5f9.zip

Products#

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

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

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0536-13930536-1393-98

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
NameUNIIKind
LIGHT MINERAL OILN6K5787QVPIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
CETETH-20I835H2IHHXIACT
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
3c3281c6-b3df-d3a8-e063-6394a90a8c6400c4c849-7db9-8264-e063-6394a90ab5f92025-08-12WarningsExact identifier
spl set id: 00c4c849-7db9-8264-e063-6394a90ab5f9

Reported adverse events (FAERS/openFDA)#

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