Dr. Smith’s Diaper Rash Ointment

Manufacturer
Mission Pharmacal | Mission Pharmacal Company
Effective date
2026-01-08
Label type
HUMAN OTC DRUG LABEL
Version
10
Source
monthly-update
Hydrated at
2026-06-03 17:52:23

Label at a glance#

ProductDR SMITHS DIAPER
Active ingredientZINC OXIDE
Label structure12 sections

Storage and handling

Store between 15 0 and 30 0 C (59 0 and 86 0 F)

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient

Zinc Oxide 10%

OTC - PURPOSE SECTION

Purpose

Skin Protectant

INDICATIONS & USAGE SECTION

Uses

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

WARNINGS SECTION

Warnings

For external use only

OTC - WHEN USING SECTION

When using this product,avoid contact with the eyes.

OTC - STOP USE SECTION

See a doctorif condition lasts more than 7 days.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep this and all drugs out of the reach of children.  If swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION SECTION

Directions

  • change wet and soiled diapers promptly
  • cleanse the diaper area
  • 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.

Storage and Handling

STORAGE AND HANDLING SECTION

Store between 15 0and 30 0C (59 0and 86 0F)

INACTIVE INGREDIENT SECTION

Inactive Ingredients

Beeswax, lanolin, mineral oil, olive oil, paraffin wax, petrolatum, purified water, thymol iodide

OTHER SAFETY INFORMATION

To reporta serious adverse event of obtain product information, call (201)-696-8400

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CartonCarton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1494206Dr. Smith's Diaper Ointment 10 % Topical OintmentPSN10
199099zinc oxide 10 % Topical OintmentPSN10
1494206zinc oxide 0.1 MG/MG Topical Ointment [Dr. Smith's Diaper Rash]SBD10
199099zinc oxide 0.1 MG/MG Topical OintmentSCD10
1494206Dr. Smith's Adult Barrier 10 % Topical OintmentSY10
1494206Dr. Smith's Diaper Ointment 10 % Topical OintmentSY10
1494206Dr. Smith's Diaper Rash 0.1 MG/MG Topical OintmentSY10
199099zinc oxide 10 % Topical OintmentSY10
199099ZNO 0.1 MG/MG Topical OintmentSY10
1494206ZNO 0.1 MG/MG Topical Ointment [Dr. Smith's Diaper Rash]SY10

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0178-0330-02DR SMITHS DIAPER56.7 g in 1 JAROINTMENT56.710
0178-0330-03DR SMITHS DIAPER85 g in 1 TUBEOINTMENT8510
0178-0330-08DR SMITHS DIAPER226.8 g in 1 JAROINTMENT226.810

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0178-0330-02GM - Gram0178-03309b4b8d22-b5ed-4887-862f-f7029646fef212012-07-24
0178-0330-03GM - Gram0178-0330e6169e17-e9eb-4418-abee-ebec10406b3512012-07-24
0178-0330-08GM - Gram0178-0330ae3c2f28-9be9-4662-912c-f860a3c081c212015-02-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
ZINC OXIDEACTIVE INGREDIENTSOI2LOH54Z6
ZINC OXIDEACTIVE MOIETYSOI2LOH54Z6
LANOLININACTIVE INGREDIENT7EV65EAW6H6
MINERAL OILINACTIVE INGREDIENTT5L8T28FGP6
OLIVE OILINACTIVE INGREDIENT6UYK2W1W1E6
PARAFFININACTIVE INGREDIENTI9O0E3H2ZE6
PETROLATUMINACTIVE INGREDIENT4T6H12BN9U6
THYMOL IODIDEINACTIVE INGREDIENTA51HJM3XSU6
WATERINACTIVE INGREDIENT059QF0KO0R6
YELLOW WAXINACTIVE INGREDIENT2ZA36H0S2V6

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0178-03300178-0330-03, 0178-0330-02, 0178-0330-08

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
92023-10-05full-release2026-05-31 23:56:27

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 · 32 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
MINERAL OILMINERAL OILT5L8T28FGPOINTMENT / TOPICAL9938 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
PARAFFINPARAFFINI9O0E3H2ZEOINTMENT / TOPICAL2860 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
YELLOW WAXYELLOW WAX2ZA36H0S2VOINTMENT / TOPICAL20 %w/wExact identifier — unii+route+dosage form
4 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPOINTMENT / TOPICAL9938 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
OLIVE OILOLIVE OIL6UYK2W1W1ESOAP / TOPICALNAExact identifier — unii+route
12 equally ranked IID candidates
OLIVE OILOLIVE OIL6UYK2W1W1ELOTION / TOPICAL32468 mgExact identifier — unii+route
12 equally ranked IID candidates
OLIVE OILOLIVE OIL6UYK2W1W1ESOLUTION / TOPICAL0.6 %w/wExact identifier — unii+route
12 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPOINTMENT / TOPICAL9938 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
LANOLINLANOLIN7EV65EAW6HOINTMENT / TOPICAL10 %w/wExact identifier — unii+route+dosage form
4 equally ranked IID candidates
PARAFFINPARAFFINI9O0E3H2ZEOINTMENT / TOPICAL2860 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
YELLOW WAXYELLOW WAX2ZA36H0S2VOINTMENT / TOPICAL20 %w/wExact identifier — unii+route+dosage form
4 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPOINTMENT / TOPICAL9938 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
OLIVE OILOLIVE OIL6UYK2W1W1ESOAP / TOPICALNAExact identifier — unii+route
12 equally ranked IID candidates
PARAFFINPARAFFINI9O0E3H2ZEOINTMENT / TOPICAL2860 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
LANOLINLANOLIN7EV65EAW6HOINTMENT / TOPICAL10 %w/wExact identifier — unii+route+dosage form
4 equally ranked IID candidates
OLIVE OILOLIVE OIL6UYK2W1W1ELOTION / TOPICAL32468 mgExact identifier — unii+route
12 equally ranked IID candidates
OLIVE OILOLIVE OIL6UYK2W1W1ESOAP / TOPICALNAExact identifier — unii+route
12 equally ranked IID candidates
LANOLINLANOLIN7EV65EAW6HOINTMENT / TOPICAL10 %w/wExact identifier — unii+route+dosage form
4 equally ranked IID candidates
YELLOW WAXYELLOW WAX2ZA36H0S2VOINTMENT / TOPICAL20 %w/wExact identifier — unii+route+dosage form
4 equally ranked IID candidates
OLIVE OILOLIVE OIL6UYK2W1W1ESOAP / TOPICALNAExact identifier — unii+route
12 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UOINTMENT / TOPICAL7275 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
OLIVE OILOLIVE OIL6UYK2W1W1ELOTION / TOPICAL32468 mgExact identifier — unii+route
12 equally ranked IID candidates
OLIVE OILOLIVE OIL6UYK2W1W1ESOLUTION / TOPICAL0.6 %w/wExact identifier — unii+route
12 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UOINTMENT / TOPICAL7275 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
OLIVE OILOLIVE OIL6UYK2W1W1ESOLUTION / TOPICAL0.6 %w/wExact identifier — unii+route
12 equally ranked IID candidates
LANOLINLANOLIN7EV65EAW6HOINTMENT / TOPICAL10 %w/wExact identifier — unii+route+dosage form
4 equally ranked IID candidates
OLIVE OILOLIVE OIL6UYK2W1W1ESOLUTION / TOPICAL0.6 %w/wExact identifier — unii+route
12 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UOINTMENT / TOPICAL7275 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
PARAFFINPARAFFINI9O0E3H2ZEOINTMENT / TOPICAL2860 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
YELLOW WAXYELLOW WAX2ZA36H0S2VOINTMENT / TOPICAL20 %w/wExact identifier — unii+route+dosage form
4 equally ranked IID candidates
OLIVE OILOLIVE OIL6UYK2W1W1ELOTION / TOPICAL32468 mgExact identifier — unii+route
12 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UOINTMENT / TOPICAL7275 mgExact identifier — unii+route+dosage form
4 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 SMITHS DIAPERZINC OXIDEMission Pharmacal7705b182-acf7-4195-9996-7d9fcdfbf0552026-01-08WarningsExact identifier
ndc (package): 0178-0330-08
ndc (package): 0178-0330-02
ndc (package): 0178-0330-03
ndc (product): 0178-0330
ndc11 (package): 00178033002
ndc11 (package): 00178033008
ndc11 (package): 00178033003
spl id: 47e710bf-d93c-068a-e063-6294a90a584b
spl set id: 7705b182-acf7-4195-9996-7d9fcdfbf055

Reported adverse events (FAERS/openFDA)#

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