Quality Choice Zinc Oxide Ointment USP

Manufacturer
Chain Drug Marketing Association Inc. | Trifecta Pharmaceuticals USA LLC | Zhejiang Jingwei Pharmaceutical Co., Ltd.
Effective date
2024-11-05
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:34:19

Label at a glance#

ProductZinc Oxide 20%
Active ingredientZINC OXIDE
Label structure10 sections

Indications and uses

Protects skin Protects and releives chafed skin due to diaper rash - helps seal out wetness Dries the oozing and weeping of poison ivy, oak and sumac

Dosage and administration

Apply ointment liberally as often as necessary For the treatment of diaper rash, change wet and soiled diapers promptly Cleanse the diaper area and allow to dry Apply with each diaper change, especially at bedtime or anytime when exposure to wet diaper may be prolonged

Storage and handling

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

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide 20%

Purpose

OTC - PURPOSE SECTION

Skin Protectant

Uses

INDICATIONS & USAGE SECTION

  • Protects skin
  • Protects and releives chafed skin due to diaper rash - helps seal out wetness
  • Dries the oozing and weeping of poison ivy, oak and sumac

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
  • Stop use and ask a doctor if condition worsens or does not improve within 7 days. This may be a sign of a serious condition.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Apply ointment liberally as often as necessary
  • For the treatment of diaper rash, change wet and soiled diapers promptly
  • Cleanse the diaper area and allow to dry
  • Apply with each diaper change, especially at bedtime or anytime when exposure to wet diaper may be prolonged

Other Information

STORAGE AND HANDLING SECTION

  • Store at controlled room temperature 15° - 30°C (59° - 86°F)

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Mineral Oil, Petrolatum

Distributed By:

SPL UNCLASSIFIED SECTION

Distributed by CDMA Inc.

Novi, MI. 48375

www.qualitychoice.com

Questions: 800-935-2362

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

99197 QC ZINC OXIDE OINTMENT 2OZ REV07 050624 CDER99197 QC ZINC OXIDE OINTMENT 2OZ REV07 050624 CDER

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
198911zinc oxide 20 % Topical OintmentPSN1
198911zinc oxide 0.2 MG/MG Topical OintmentSCD1
198911zinc oxide 20 % Topical OintmentSY1
198911zinc oxide 200 MG per GM Topical OintmentSY1
198911ZNO 0.2 MG/MG Topical OintmentSY1

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83324-052-01Zinc Oxide 20%1 in 1 BOXOINTMENT11
83324-052-01Zinc Oxide 20%57 g in 1 TUBEOINTMENT571

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83324-052ZINC OXIDE 20% (ZINC OXIDE) OINTMENT [CHAIN DRUG MARKETING ASSOCIATION INC.]1Current NDC, 2 package rows20241107_262f8cab-c7b8-b07e-e063-6294a90a1289.zip

Products#

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

DailyMed product names page 1 of 1 · 4 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
83324-05283324-052-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
NameUNIIKind
MINERAL OILT5L8T28FGPIACT
PETROLATUM4T6H12BN9UIACT
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
Zinc Oxide 20%ZINC OXIDEChain Drug Marketing Association Inc.262f8cab-c7b8-b07e-e063-6294a90a12892024-11-05WarningsExact identifier
ndc (package): 83324-052-01
ndc (product): 83324-052
ndc11 (package): 83324005201
spl id: 262f8a7e-40f3-8fa9-e063-6394a90a762e
spl set id: 262f8cab-c7b8-b07e-e063-6294a90a1289

Reported adverse events (FAERS/openFDA)#

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