Quality Choice Zinc Oxide Ointment USP

Manufacturer: Chain Drug Marketing Association Inc. | Trifecta Pharmaceuticals USA LLC
Effective date: 2023-05-23
Label type: HUMAN OTC DRUG LABEL
Version: 3
Source: full-release
Hydrated at: 2026-05-31 23:55:04

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)

Contacts and useful links#

PhoneLabel contact800-935-2362

Websitewww.qualitychoice.com

www.qualitychoice.com

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.

43157 W 9 Mile Rd

Novi, MI. 48375

Product of PRC

www.qualitychoice.com

Questions: 800-935-2362

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

QC zinc oxide 2oz

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
198911	zinc oxide 20 % Topical Ointment	PSN	3
198911	zinc oxide 0.2 MG/MG Topical Ointment	SCD	3
198911	zinc oxide 20 % Topical Ointment	SY	3
198911	zinc oxide 200 MG per GM Topical Ointment	SY	3
198911	ZNO 0.2 MG/MG Topical Ointment	SY	3

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
63868-686-02	2025-01-30	C162847	48780-1	f386c64a-3b84-0266-e053-dadaa90a7c1a	Quality Choice Zinc Oxide Ointment USP
63868-686-02	2023-05-23	C162847	48780-1	f386c64a-3b84-0266-e053-dadaa90a7c1a	Quality Choice Zinc Oxide Ointment USP
63868-686-02	2023-01-30	C162847	48780-1	f386c64a-3b84-0266-e053-dadaa90a7c1a	Quality Choice Zinc Oxide Ointment USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
63868-686-02	Zinc Oxide 20%	1 in 1 BOX	OINTMENT	1		3
63868-686-02	Zinc Oxide 20%	57 g in 1 TUBE	OINTMENT	57		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63868-686	ZINC OXIDE 20% (ZINC OXIDE) OINTMENT [CHAIN DRUG MARKETING ASSOCIATION INC.]	3	Legacy NDC, 2 package rows	20230525_acdb3a7d-415b-e823-e053-2995a90a654c.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63868-686-02	GM - Gram	63868-686	8cc1d8f3-95a6-449b-aa36-3f84e743218a	1	2022-09-12

Products#

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

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

Zinc Oxide 20%
Zinc Oxide
MINERAL OIL
PETROLATUM

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
63868-686	63868-686-02

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
Name	UNII	Kind
MINERAL OIL	T5L8T28FGP	IACT
PETROLATUM	4T6H12BN9U	IACT
ZINC OXIDE	SOI2LOH54Z	ACTIB

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
fc61822a-3fbd-343c-e053-6294a90af72c			acdb3a7d-415b-e823-e053-2995a90a654c	2023-05-23	Warnings	Exact identifier spl id: fc61822a-3fbd-343c-e053-6294a90af72c spl set id: acdb3a7d-415b-e823-e053-2995a90a654c

Reported adverse events (FAERS/openFDA)#

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