FDA.reportPublic FDA data

Diaper Rash Ointment

Manufacturer
Pharmacy Value Alliance, LLC | Trifecta Pharmaceuticals USA LLC
Effective date
2024-12-20
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
full-release
Hydrated at
2026-06-01 00:47:24

Label at a glance#

ProductDiaperRashOintment
Active ingredientZINC OXIDE
Label structure11 sections

Indications and uses

Helps treat and prevent diaper rash Protects chafed skin due to diaper rash and helps protect skin from 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.

Storage and handling

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

Label contents#

Full prescribing information#

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 protect skin from wetness

Keep out of the reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center immediately.

Warnings

WARNINGS SECTION

For External Use Only

When using this product

  • Avoid contact with eyes

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.

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 with a few days

Other Information:

STORAGE AND HANDLING SECTION

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

Inactive Ingredients

INACTIVE INGREDIENT SECTION

BHA, Cod liver oil (high in vitamin A and D), Frangrance, Lanolin, Mineral Oil, Methylparaben, Petrolatum, Purified water, Talc, Tartrazine yellow #4 (FD and C yellow #4)

Helps treat and prevent diaper rash. Protects skin. Relieves Chafing. Promotes Healing

SPL UNCLASSIFIED SECTION

Distributed by:

Pharmacy Value Alliance, LLC.

407 East Lancaster Avenue, Wayne, PA. 19087 USA

www.emersongroup.com

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PackagingPackaging

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
244638zinc oxide 40 % Topical OintmentPSN7
244638zinc oxide 0.4 MG/MG Topical OintmentSCD7
244638zinc oxide 40 % Topical OintmentSY7
244638ZNO 0.4 MG/MG Topical OintmentSY7

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68016-128-202023-05-08C16284748780-1ba0f9c33-2345-a910-e053-dadaa90a0b85Diaper Rash Ointment
68016-128-202021-01-29C16284748780-1ba0f9c33-2345-a910-e053-dadaa90a0b85Diaper Rash Ointment

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68016-128-20DiaperRashOintment113 g in 1 TUBEOINTMENT1137

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68016-128DIAPERRASHOINTMENT (ZINC OXIDE) OINTMENT [PHARMACY VALUE ALLIANCE, LLC]7Current NDC, Legacy NDC, 1 package rows20241222_3aace6d8-d24c-00e1-e054-00144ff8d46c.zip

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68016-12868016-128-20

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
POLYSORBATE 806OZP39ZG8HIACT
ALPHA-TOCOPHEROL ACETATE9E8X80D2L0IACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
PROPYLPARABENZ8IX2SC1OHIACT
METHYLPARABENA2I8C7HI9TIACT
ALOE VERA LEAFZY81Z83H0XIACT
PETROLATUM4T6H12BN9UIACT
YELLOW WAX2ZA36H0S2VIACT
STEARIC ACID4ELV7Z65APIACT
ZINC OXIDESOI2LOH54ZACTIB
MINERAL OILT5L8T28FGPIACT
WATER059QF0KO0RIACT

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
DiaperRashOintmentZINC OXIDEPharmacy Value Alliance, LLC3aace6d8-d24c-00e1-e054-00144ff8d46c2024-12-20WarningsExact identifier
ndc (package): 68016-128-20
ndc (product): 68016-128
ndc11 (package): 68016012820
spl id: 29b767b1-aee6-2365-e063-6294a90a6778
spl set id: 3aace6d8-d24c-00e1-e054-00144ff8d46c

Reported adverse events (FAERS/openFDA)#

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