ElixirZincoCare

Manufacturer: ELIXIR HEALTHCARE USA, LLC.
Effective date: 2025-11-22
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-06-01 01:29:26

Label at a glance#

ProductElixirZincoCare

Active ingredientZINC OXIDE

Label structure14 sections

Indications and uses

helps treat and prevent diaper rash. Protects chafed skin due to diaper rash and helps seal out wetness. dries the oozing and weeping of poison ivy, poison oak and poison sumac

Dosage and administration

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

Label contents#

Full prescribing information#

Active Ingredient (in each gram)

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide 20% w/w

Purpose

OTC - PURPOSE SECTION

First Aid Antibiotic

Uses

INDICATIONS & USAGE SECTION

helps treat and prevent diaper rash. Protects chafed skin due to diaper rash and helps seal out wetness. dries the oozing and weeping of poison ivy, poison oak and poison sumac

Warnings

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

• For external use only
• When using this product, avoid contact with the eyes
• Stop use and ask a doctor if condition worsens or does not improve within 7 days
Keep out of reach of children. If swallowed, get medical help or contact a poison control center right away

Ask a doctor before use in case of

OTC - ASK DOCTOR SECTION

• deep or puncture wounds
• animal bites
• serious burns

Stop use and ask a doctor if

OTC - STOP USE SECTION

• condition persists or gets worse
• a rash or other allergic reaction develops

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

Cetostearyl Alcohol, Cetomacrogol-1000, Lanoline Anhydrous, White Petroleum Jelly, Light Liquid Paraffin

Other information

SPL UNCLASSIFIED SECTION

• Store at USP controlled room temperature 20-25°C (68-77°F)
• To open: unscrew cap, remove liner seal and replace cap.
• see carton or tube crimp for lot number and expiration date

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Zinc Oxide Ointment

Skin Protectant • 2 oz

Reorder No. xxxx

Individually Boxed • 12 Tubes per Pack

Each Tube Net Weight 2 oz

Gross Wt. 5.300 kg Net Wt. 4.075 kg

72 Tubes

Elixir

12tubes

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Zinc Oxide Ointment

Skin Protectant • 1 oz

Net Wt. 1 OZ (28.3 g)

Reorder No. xxxx

Elixir

Tube Lable.jpg

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ZINC OXIDE OINTMENT

ZINC OXIDE 20%

Skin Protectant

15 OZ. Jars • 12 Jars per Case

Reorder No.: ______

jar

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
198911	zinc oxide 20 % Topical Ointment	PSN	1
198911	zinc oxide 0.2 MG/MG Topical Ointment	SCD	1
198911	zinc oxide 20 % Topical Ointment	SY	1
198911	zinc oxide 200 MG per GM Topical Ointment	SY	1
198911	ZNO 0.2 MG/MG Topical Ointment	SY	1

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
ZINC CATION Pharmacologic Class Indexing	2	Indexing - Pharmacologic Class	20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
f47a510b-6679-4664-b2d6-47b5c4afe7cc	Product name	4	20260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61c	Product name	2	20250515
0306390c-dd77-4363-afe0-63c58088b2a1	Product name	1	20220120
503ea967-4b9c-48cf-9e87-c7975295849d	Product name	2	20220120
190f2a5b-bbc8-65c7-fcb0-97891307b917	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
84546-0004-1	ElixirZincoCare	28.3 g in 1 TUBE	OINTMENT	28.3	1
84546-0004-1	ElixirZincoCare	1 in 1 CARTON	OINTMENT	1	1
84546-0004-2	ElixirZincoCare	12 in 1 BOX	OINTMENT	12	1
84546-0004-2	ElixirZincoCare	6 in 1 CASE	OINTMENT	6	1
84546-0004-3	ElixirZincoCare	454 g in 1 JAR	OINTMENT	454	1

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

ElixirZincoCare
Zinc Oxide 20%
CETOSTEARYL ALCOHOL
CETETH-20
WHITE PETROLATUM
PARAFFIN
ZINC OXIDE
ZINC CATION

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
84546-0004	84546-0004-1, 84546-0004-2, 84546-0004-3

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
CETOSTEARYL ALCOHOL	2DMT128M1S	IACT
CETETH-20	I835H2IHHX	IACT
WHITE PETROLATUM	B6E5W8RQJ4	IACT
PARAFFIN	I9O0E3H2ZE	IACT
ZINC OXIDE	SOI2LOH54Z	ACTIM

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N000004-004	PAREDRINE	HYDROXYAMPHETAMINE HYDROBROMIDE	1%	SOLUTION/DROPS / OPHTHALMIC		Approved before 1982

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Source SHA-256
2026-10-15 13:18:30	2026-09	N000004-004	PAREDRINE	1%	SOLUTION/DROPS / OPHTHALMIC	Approved before 1982	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N000004-004	PAREDRINE	1%	SOLUTION/DROPS / OPHTHALMIC	Approved before 1982	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N000004-004	PAREDRINE	1%	SOLUTION/DROPS / OPHTHALMIC	Approved before 1982	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N000004-004	PAREDRINE	1%	SOLUTION/DROPS / OPHTHALMIC	Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N000004-004	PAREDRINE	1%	SOLUTION/DROPS / OPHTHALMIC	Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N000004-004	PAREDRINE	1%	SOLUTION/DROPS / OPHTHALMIC	Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N000004-004	PAREDRINE	1%	SOLUTION/DROPS / OPHTHALMIC	Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N000004-004	PAREDRINE	1%	SOLUTION/DROPS / OPHTHALMIC	Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N000004-004	PAREDRINE	1%	SOLUTION/DROPS / OPHTHALMIC	Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N000004-004	PAREDRINE	1%	SOLUTION/DROPS / OPHTHALMIC	Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N000004-004	PAREDRINE	1%	SOLUTION/DROPS / OPHTHALMIC	Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N000004-004	PAREDRINE	1%	SOLUTION/DROPS / OPHTHALMIC	Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N000004-004	PAREDRINE	1%	SOLUTION/DROPS / OPHTHALMIC	Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N000004-004	PAREDRINE	1%	SOLUTION/DROPS / OPHTHALMIC	Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N000004-004	PAREDRINE	1%	SOLUTION/DROPS / OPHTHALMIC	Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N000004-004	PAREDRINE	1%	SOLUTION/DROPS / OPHTHALMIC	Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N000004-004	PAREDRINE	1%	SOLUTION/DROPS / OPHTHALMIC	Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N000004-004	PAREDRINE	1%	SOLUTION/DROPS / OPHTHALMIC	Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N000004-004	PAREDRINE	1%	SOLUTION/DROPS / OPHTHALMIC	Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N000004-004	PAREDRINE	1%	SOLUTION/DROPS / OPHTHALMIC	Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N000004-004	PAREDRINE	1%	SOLUTION/DROPS / OPHTHALMIC	Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N000004-004	PAREDRINE	1%	SOLUTION/DROPS / OPHTHALMIC	Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N000004-004	PAREDRINE	1%	SOLUTION/DROPS / OPHTHALMIC	Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N000004-004	PAREDRINE	1%	SOLUTION/DROPS / OPHTHALMIC	Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N000004-004	PAREDRINE	1%	SOLUTION/DROPS / OPHTHALMIC	Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N000004-004	PAREDRINE	1%	SOLUTION/DROPS / OPHTHALMIC	Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N000004-004	PAREDRINE	1%	SOLUTION/DROPS / OPHTHALMIC	Approved before 1982	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N000004-004	PAREDRINE	1%	SOLUTION/DROPS / OPHTHALMIC	Approved before 1982	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N000004-004	PAREDRINE	1%	SOLUTION/DROPS / OPHTHALMIC	Approved before 1982	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N000004-004	PAREDRINE	1%	SOLUTION/DROPS / OPHTHALMIC	Approved before 1982	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N000004-004	PAREDRINE	1%	SOLUTION/DROPS / OPHTHALMIC	Approved before 1982	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N000004-004	PAREDRINE	1%	SOLUTION/DROPS / OPHTHALMIC	Approved before 1982	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N000004-004	PAREDRINE	1%	SOLUTION/DROPS / OPHTHALMIC	Approved before 1982	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N000004-004	PAREDRINE	1%	SOLUTION/DROPS / OPHTHALMIC	Approved before 1982	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N000004-004	PAREDRINE	1%	SOLUTION/DROPS / OPHTHALMIC	Approved before 1982	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N000004-004	PAREDRINE	1%	SOLUTION/DROPS / OPHTHALMIC	Approved before 1982	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N000004-004	PAREDRINE	1%	SOLUTION/DROPS / OPHTHALMIC	Approved before 1982	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N000004-004	PAREDRINE	1%	SOLUTION/DROPS / OPHTHALMIC	Approved before 1982	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N000004-004	PAREDRINE	1%	SOLUTION/DROPS / OPHTHALMIC	Approved before 1982	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N000004-004	PAREDRINE	1%	SOLUTION/DROPS / OPHTHALMIC	Approved before 1982	`3a93d1ddd44b…`

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
ElixirZincoCare	ZINC OXIDE 20%	ELIXIR HEALTHCARE USA, LLC.	bac18496-3b76-4faf-abde-968d79b718d8	2025-11-22	Warnings	Exact identifier ndc (package): 84546-0004-1 ndc (package): 84546-0004-3 ndc (package): 84546-0004-2 ndc (product): 84546-0004 ndc11 (package): 84546000401 ndc11 (package): 84546000402 ndc11 (package): 84546000403 spl id: 44302810-1a9c-cd23-e063-6394a90a964f spl set id: bac18496-3b76-4faf-abde-968d79b718d8

Reported adverse events (FAERS/openFDA)#

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