FDA.reportPublic FDA data

Dr. Sheffield Diaper Rash

Manufacturer
Sheffield Pharmaceuticals LLC
Effective date
2023-11-28
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:02:51

Label at a glance#

ProductDr. Sheffield Diaper Rash
Active ingredientZINC OXIDE
Label structure10 sections

Indications and uses

helps treat and prevent diaper rash protects chafed skin due to diaper rash and helps seal out wetness

Dosage and administration

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

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide 40%

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

Warnings

WARNINGS SECTION

For external use only

SPL UNCLASSIFIED SECTION

When using this product

OTC - WHEN USING SECTION

  • avoid contact with eyes

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

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

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

Other information

OTHER SAFETY INFORMATION

store at room temperature 15° - 30°C (59° - 86°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

BHA, Cod liver oil, Fragrance, Lanolin, Petrolatum, Talc, Water

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principal Display Panel - Carton Label

NDC 11527-058-41

Dr. Sheffield's

Made in the USA

Diaper Rash
Ointment

40% Zinc Oxide Skin Protectant

• Promotes healing

• Relieves chafing

• Paraben free

Helps Treat and
Prevent Diaper Rash

NET WT. 2 oz. (56g)

Principal Display Panel - Carton LabelPrincipal Display Panel - Carton Label

Principal Display Panel - Carton LabelPrincipal Display Panel - Carton Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principal Display Panel - Tube Label

NDC 11527-058-41

Dr. Sheffield's

Made in the USA

Diaper Rash
Ointment

NET WT. 2 oz. (56g)

40% Zinc Oxide Skin Protectant

Helps Treat and Prevent Diaper Rash

Principal Display Panel - Tube LabelPrincipal Display Panel - Tube Label

Principal Display Panel - Tube LabelPrincipal Display Panel - Tube Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
244638zinc oxide 40 % Topical OintmentPSN4
244638zinc oxide 0.4 MG/MG Topical OintmentSCD4
244638zinc oxide 40 % Topical OintmentSY4
244638ZNO 0.4 MG/MG Topical OintmentSY4

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11527-058-40Dr. Sheffield Diaper Rash28 g in 1 TUBEOINTMENT284
11527-058-40Dr. Sheffield Diaper Rash1 in 1 CARTONOINTMENT14
11527-058-41Dr. Sheffield Diaper Rash56 g in 1 TUBEOINTMENT564
11527-058-41Dr. Sheffield Diaper Rash1 in 1 CARTONOINTMENT14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11527-058DR. SHEFFIELD DIAPER RASH (ZINC OXIDE) OINTMENT [SHEFFIELD PHARMACEUTICALS LLC]4Current NDC, Legacy NDC, 4 package rows20231129_cac77320-b5cf-4edf-9693-ebabfb61390c.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
11527-058-41GM - Gram11527-05801e5a460-122f-4378-81d1-b67ba2d5ddb412021-06-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
ZINC OXIDEACTIVE INGREDIENTSOI2LOH54Z1
ZINC OXIDEACTIVE MOIETYSOI2LOH54Z1
BUTYLATED HYDROXYANISOLEINACTIVE INGREDIENTREK4960K2U1
COD LIVER OILINACTIVE INGREDIENTBBL281NWFG1
LANOLININACTIVE INGREDIENT7EV65EAW6H1
PETROLATUMINACTIVE INGREDIENT4T6H12BN9U1
TALCINACTIVE INGREDIENT7SEV7J4R1U1
WATERINACTIVE INGREDIENT059QF0KO0R1

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
11527-05811527-058-41, 11527-058-40

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
ZINC OXIDESOI2LOH54ZACTIB
BUTYLATED HYDROXYANISOLEREK4960K2UIACT
COD LIVER OILBBL281NWFGIACT
LANOLIN7EV65EAW6HIACT
PETROLATUM4T6H12BN9UIACT
TALC7SEV7J4R1UIACT
WATER059QF0KO0RIACT

Source Document#

Source XML · Source PDF

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 12 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
PETROLATUMPETROLATUM4T6H12BN9UOINTMENT / TOPICAL7275 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UOINTMENT / TOPICAL7275 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
TALCTALC7SEV7J4R1UOINTMENT / TOPICAL74.6 %w/wExact identifier — unii+route+dosage form
3 equally ranked IID candidates
TALCTALC7SEV7J4R1UOINTMENT / TOPICAL74.6 %w/wExact identifier — unii+route+dosage form
3 equally ranked IID candidates
LANOLINLANOLIN7EV65EAW6HOINTMENT / TOPICAL10 %w/wExact identifier — unii+route+dosage form
3 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UOINTMENT / TOPICAL7275 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
BUTYLATED HYDROXYANISOLEBUTYLATED HYDROXYANISOLEREK4960K2UOINTMENT / TOPICAL0.01 %w/wExact identifier — unii+route+dosage form
3 equally ranked IID candidates
TALCTALC7SEV7J4R1UOINTMENT / TOPICAL74.6 %w/wExact identifier — unii+route+dosage form
3 equally ranked IID candidates
LANOLINLANOLIN7EV65EAW6HOINTMENT / TOPICAL10 %w/wExact identifier — unii+route+dosage form
3 equally ranked IID candidates
BUTYLATED HYDROXYANISOLEBUTYLATED HYDROXYANISOLEREK4960K2UOINTMENT / TOPICAL0.01 %w/wExact identifier — unii+route+dosage form
3 equally ranked IID candidates
LANOLINLANOLIN7EV65EAW6HOINTMENT / TOPICAL10 %w/wExact identifier — unii+route+dosage form
3 equally ranked IID candidates
BUTYLATED HYDROXYANISOLEBUTYLATED HYDROXYANISOLEREK4960K2UOINTMENT / TOPICAL0.01 %w/wExact identifier — unii+route+dosage form
3 equally ranked IID candidates

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
Dr. Sheffield Diaper RashZINC OXIDESheffield Pharmaceuticals LLCcac77320-b5cf-4edf-9693-ebabfb61390c2023-11-28WarningsExact identifier
ndc (package): 11527-058-40
ndc (package): 11527-058-41
ndc (product): 11527-058
ndc11 (package): 11527005841
ndc11 (package): 11527005840
spl id: 569610c1-6c56-4437-a651-2004d621d8ac
spl set id: cac77320-b5cf-4edf-9693-ebabfb61390c

Reported adverse events (FAERS/openFDA)#

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