Dr. Sheffield Barrier Cream

Manufacturer
Sheffield Pharmaceuticals, LLC
Effective date
2017-05-05
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 01:13:59

Label at a glance#

ProductDr. Sheffield Barrier Cream
Active ingredientZINC OXIDE, MENTHOL
Label structure11 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 doctorDo not put prodcut 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.

Directions

DOSAGE & ADMINISTRATION SECTION

<Adults: When practical ,cleanse the affected areawith a mild soap and warm water and rinse thorughly. Gently dry by pattingor blotting with toilet tissue or a soft cloth beforeapplication of this product.Children under 12 years of age: consult a doctor. Apply extrenally to the affectedarea u pto 6 times a day.>

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 11527-213-22

Dr. Sheffield's

Made in the USA

Dual action Barrier Cream with pain relief

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 Label
Principal Display Panel - Tube Label

Principal Display Panel - Packet

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principal Display Panel - PacketPrincipal Display Panel - Packet

NDC # 11527-213-75

Dr. Sheffield's  Made in the USA

Dual Action Barrier Cream with Pain Relief 

0.45% Menthol - External Analgesic

20% Zinc Oxide -Astrigent 

  • Soothes and protects irritaed or chafed skin associated with incontinence 
  • Temporarily relief of pain & itching

NET WT 4g( 1/7oz)

Principal Display Panel - Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principal Display Panel - CartonPrincipal Display Panel - Carton

NDC# 11527-213-75

Dr. Sheffield's  Made in the USA

Dual Action Barrier Cream 

0.45% Menthol

20% Zinc Oxide 

  • Soothes and protects irritated or chafed skin associated with incontinence
  • Provided temporary relief of pain & itching
1 GROSS ( 144pcs.)Net Wt. 4 g (1/7 oz) packets 

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
11527-213-22GM - Gram11527-213f69b4b56-f8c0-4f4c-83f0-b6fd973a3be512022-06-06

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
11527-21311527-213-22, 11527-213-75

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
57af7d5f-70ee-4945-a9ef-f57dba6bf6b0de3580fb-e167-4ee7-adc5-fe43ac10ae1d2022-09-22WarningsExact identifier
spl set id: de3580fb-e167-4ee7-adc5-fe43ac10ae1d

Reported adverse events (FAERS/openFDA)#

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