FDA.reportPublic FDA data

AQUAGARD

Manufacturer
Dynarex Corporation
Effective date
2024-11-20
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
legacy-cache
Hydrated at
2026-08-01 20:48:57

Label at a glance#

ProductAQUAGARD
Active ingredientPETROLATUM
Label structure11 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.

Storage and handling

Store at room temperature (59°-86°F).

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Petrolatum 41%

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

STORAGE AND HANDLING SECTION

Store at room temperature (59°-86°F).

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

Questions?

OTC - QUESTIONS SECTION

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

Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

1463 Principal Display Panel1463 Principal Display Panel

Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

1464 IN MASTER1464 IN MASTER

Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

1465 DM MASTER1465 DM MASTER1465 BX MASTER1465 BX MASTER

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67777-014AQUAGARD (HYDRATING OINTMENT) OINTMENT [DYNAREX CORPORATION]5Legacy NDC20241122_812b71ea-48ee-7e5e-e053-2a91aa0a7e57.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67777-014-03GM - Gram67777-01441ace1dc-dd59-4d59-9238-3b91e07dcf5d12023-08-08
67777-014-04GM - Gram67777-014cf706574-a27c-4f7b-a632-dfee55e8325b12023-08-08
67777-014-05EA - Each67777-01493f916b8-c8c9-4039-9fd1-b31869d2537e12023-08-08
67777-014-63GM - Gram67777-014ca7162c1-bdc4-41f1-98aa-a9f07bc829bb12023-08-08
67777-014-64GM - Gram67777-014ce872799-0625-42de-a300-577b1d46a7da12023-08-08
67777-014-65EA - Each67777-014af79ff9d-25c6-4500-9984-48f47cffa22312023-08-08

Products#

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

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

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
67777-01467777-014-03, 67777-014-63, 67777-014-04, 67777-014-64, 67777-014-05, 67777-014-65

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
GLYCERINPDC6A3C0OXIACT
PETROLATUM4T6H12BN9UACTIB
MINERAL OILT5L8T28FGPIACT
LANOLIN ALCOHOLS884C3FA9HEIACT
CERESINQ1LS2UJO3AIACT
DEXPANTHENOL1O6C93RI7ZIACT

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
47ce7ef7-029b-146b-e063-6294a90a0f95812b71ea-48ee-7e5e-e053-2a91aa0a7e572026-01-07WarningsExact identifier
spl set id: 812b71ea-48ee-7e5e-e053-2a91aa0a7e57

Reported adverse events (FAERS/openFDA)#

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