FDA.reportPublic FDA data

Quality Choice Diaper Rash Ointment

Manufacturer
Chain Drug Marketing Association Inc. | Trifecta Pharmaceuticals USA LLC
Effective date
2023-05-23
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-05-31 23:55:03

Label at a glance#

ProductQuality Choice Diaper Rash
Active ingredientZINC OXIDE
Label structure13 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

This product contains trace amounts of naturally occuring lead.

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)

Questions

OTC - QUESTIONS SECTION

1-800-935-2362

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:

C.D.M.A., Inc. ©

43157 W 9 Mile Rd

Novi, MI. 48375 USA

www.qualitychoice.com

Product of PRC

Other Information

SPL UNCLASSIFIED SECTION

This product is not manufactured or distributed by Johnson & Johnson Consumer Company Inc. owner of the registered trademark Desitin®.

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

qc diaper rashqc diaper rash

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
244638zinc oxide 40 % Topical OintmentPSN5
244638zinc oxide 0.4 MG/MG Topical OintmentSCD5
244638zinc oxide 40 % Topical OintmentSY5
244638ZNO 0.4 MG/MG Topical OintmentSY5

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63868-948-042025-01-30C16284748780-1f386c64a-2105-0266-e053-dadaa90a7c1aQuality Choice Diaper Rash Ointment
63868-948-042023-05-23C16284748780-1f386c64a-2105-0266-e053-dadaa90a7c1aQuality Choice Diaper Rash Ointment
63868-948-042023-01-30C16284748780-1f386c64a-2105-0266-e053-dadaa90a7c1aQuality Choice Diaper Rash Ointment

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63868-948-04Quality Choice Diaper Rash113 g in 1 TUBEOINTMENT1135

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63868-948QUALITY CHOICE DIAPER RASH (ZINC OXIDE) OINTMENT [CHAIN DRUG MARKETING ASSOCIATION INC.]5Legacy NDC, 1 package rows20230525_9a1184f5-64d8-9786-e053-2a95a90a03b8.zip

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
63868-94863868-948-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
TALC7SEV7J4R1UIACT
BUTYLATED HYDROXYTOLUENE1P9D0Z171KIACT
LANOLIN7EV65EAW6HIACT
FD&C YELLOW NO. 5I753WB2F1MIACT
COD LIVER OILBBL281NWFGIACT
LIGHT MINERAL OILN6K5787QVPIACT
METHYLPARABENA2I8C7HI9TIACT
PETROLATUM4T6H12BN9UIACT
WATER059QF0KO0RIACT
ZINC OXIDESOI2LOH54ZACTIB

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
fc619907-ae29-d730-e053-6394a90a072e9a1184f5-64d8-9786-e053-2a95a90a03b82023-05-23WarningsExact identifier
spl id: fc619907-ae29-d730-e053-6394a90a072e
spl set id: 9a1184f5-64d8-9786-e053-2a95a90a03b8

Reported adverse events (FAERS/openFDA)#

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