AquaGard

Manufacturer: Dynarex Corporation
Effective date: 2019-01-09
Label type: HUMAN OTC DRUG LABEL
Version: 2
Source: full-release
Hydrated at: 2026-05-31 22:58:09

Label at a glance#

ProductAquaGard

Active ingredientPETROLATUM

Label structure9 sections

Indications and uses

Temporarily protects minor cuts, scrapes, burns Temporarily protects and helps relieve dry, chapped, or cracked skin and lips Helps protect skin from the drying effects of wind and cold weather

Dosage and administration

Apply as needed or as directed by a physician.

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Petrolatum 44.28%

Purpose

OTC - PURPOSE SECTION

Skin Protectant

Uses

INDICATIONS & USAGE SECTION

Temporarily protects minor cuts, scrapes, burns
Temporarily protects and helps relieve dry, chapped, or cracked skin and lips
Helps protect skin from the drying effects of wind and cold weather

Warnings

WARNINGS SECTION

For External Use Only

Avoid contact with eyes. In case of contact, flush thoroughly with water.

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 within a few days

Do not use

OTC - DO NOT USE SECTION

on deep puncture wounds, animal bites, or serious burns.

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 as needed or as directed by a physician.

Other information

OTHER SAFETY INFORMATION

Store at room temperature (59° - 86°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

Ceresin Wax, Dexpanthenol, Glycerin, Lanolin Alcohol, Mineral Oil

Questions?

OTC - QUESTIONS SECTION

1-888-DYNAREX Monday-Friday, 9AM-5PM EST

Labeling

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

1463 Aquaguard Packaging Label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
67777-146-30	2023-01-30	C162847	48780-1	f386c649-dc13-0266-e053-dadaa90a7c1a	1463 NDC 67777-146-30

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
67777-146-30	AquaGard	106 g in 1 TUBE	OINTMENT	106		2
67777-146-30	AquaGard	24 in 1 CASE	OINTMENT	24		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
67777-146	AQUAGARD (HYDRATING OINTMENT) OINTMENT [DYNAREX CORPORATION]	2	Legacy NDC, 2 package rows	20190110_79edf831-b743-607e-e053-2a91aa0a9c4f.zip

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

AquaGard
Hydrating Ointment
MINERAL OIL
LANOLIN ALCOHOLS
PARAFFIN
PETROLATUM

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
67777-146	67777-146-30

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
MINERAL OIL	T5L8T28FGP	IACT
LANOLIN ALCOHOLS	884C3FA9HE	IACT
PARAFFIN	I9O0E3H2ZE	IACT
PETROLATUM	4T6H12BN9U	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
7f0a5b22-9163-054a-e053-2991aa0a0eef			79edf831-b743-607e-e053-2a91aa0a9c4f	2019-01-09	Warnings	Exact identifier spl id: 7f0a5b22-9163-054a-e053-2991aa0a0eef spl set id: 79edf831-b743-607e-e053-2a91aa0a9c4f

Reported adverse events (FAERS/openFDA)#

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