Rugby Barrier Cream

Manufacturer
Rugby Laboratories | Sheffield Pharmaceuticals, LLC
Effective date
2019-05-03
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 00:24:35

Label at a glance#

ProductRugby Barrier Cream
Active ingredientZINC OXIDE, MENTHOL
Label structure9 sections

Indications and uses

Multipurpose moisture barrier that aids in protecting irritated skin conditions in the perineum, buttocks, lower abdomen and inner thigh due to moisture, occlusion, chafing or continued contact with urine or feces. Helps relieve the local itching, discomfort, pain, burning and irritation associated with anorectal disorders and hemorroids.May provide a cooling sensation. 

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Menthol 0.45%

Zinc Oxide 20%

Purpose

OTC - PURPOSE SECTION

External Analgesic

Astringent

Uses

INDICATIONS & USAGE SECTION

Multipurpose moisture barrier that aids in protecting irritated skin conditions in the perineum, buttocks, lower abdomen and inner thigh due to moisture, occlusion, chafing or continued contact with urine or feces.

Helps relieve the local itching, discomfort, pain, burning and irritation associated with anorectal disorders and hemorroids.May provide a cooling sensation. 

Warnings

WARNINGS SECTION

For external use only

SPL UNCLASSIFIED SECTION

Stop use and consult a doctor  •in case of bleeding  •if conditions worsenor deos not improve within 7 days

OTC - STOP USE SECTION

<Do not exceed recommended daily dosage unless directed by a doctor. Do not put product into rectum by using fingers or any mechanical device or applicatorAllergy Alert:Certain persons can develop allergic reactions to this product. If the symptoms develop or increase,discontinue use and consult a doctor. >

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 right away.

Other information

OTHER SAFETY INFORMATION

Store at controlled room temperature 20° - 25°C (68° - 77°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

Calamine, Codliver Oil, Disodium EDTA, Lanolin, Methylparaben, Microcrystalline Wax, Mineral Oil, Petrolatum, Propylparaben, Sodium Borate, Sorbitan Sequioleate, Talc, Water (Purified)

Principal Display Panel - Tube Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principal Display Panel - Tube LabelPrincipal Display Panel - Tube Label

NDC 0536-1204-73

Rugby

Menthol Zinc Ointment

Anorectal Cream 

0.45% Menthol -External Analgesic 

20% Zinc Oxide -Astringent 

• Protect and soothes irritated or chafed skin associated with incontinence 

• Temporary relief of pain & itching

NET WT. 4 oz. (113g)

Principal Display Panel - Tube LabelPrincipal Display Panel - Tube Label

Principal Display Panel - Tube Label
Principal Display Panel - Tube Label

Principal Display Panel - Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principal Display Panel - CartonPrincipal Display Panel - Carton

NDC 0536-1204-73

Rugby

Menthol Zinc Ointment

Anorectal Cream  

0.45% Menthol

20% Zinc Oxide 

Net Wt. 4 oz 113 g 

Principal Display Panel - CartonPrincipal Display Panel - Carton

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0536-1204-732024-11-15C16284748780-1ba0f9c33-4f91-a910-e053-dadaa90a0b855797b7b0-d5b2-41da-9825-245cc9b6f348
0536-1204-732021-01-29C16284748780-1ba0f9c33-4f91-a910-e053-dadaa90a0b855797b7b0-d5b2-41da-9825-245cc9b6f348

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0536-1204-73GM - Gram0536-1204b459e49e-3a8a-461f-9f52-a0101548130912019-08-06

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0536-12040536-1204-73

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 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
6a1b3823-7b1f-4c28-b74d-889ccd7b37035797b7b0-d5b2-41da-9825-245cc9b6f3482024-11-15WarningsExact identifier
spl set id: 5797b7b0-d5b2-41da-9825-245cc9b6f348

Reported adverse events (FAERS/openFDA)#

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