FDA.reportPublic FDA data

AquaSoothe

Manufacturer
Dynarex Corporation
Effective date
2025-12-09
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:23:36

Label at a glance#

ProductAquaSoothe
Active ingredientPETROLATUM
Label structure11 sections

Indications and uses

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

Dosage and administration

Apply as needed

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 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

Do not get into eyes

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 with a few days

Do not use

OTC - DO NOT USE SECTION

• On deep or puncture wounds • Animal bites • Serious burns

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 (1-800-222-1222) right away.

Other information

OTHER SAFETY INFORMATION

• Store at room temperature 15º - 30ºC (59º - 86ºF)

Directions

DOSAGE & ADMINISTRATION SECTION

Apply as needed

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

1465_BX_MASTER1465_BX_MASTER1465 Label

Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

1464_IN_MASTER1464_IN_MASTER1464 Label

Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

1463_IN_MASTER1463_IN_MASTER1463 Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
725145petrolatum 41 % Topical OintmentPSN1
725145petrolatum 0.41 MG/MG Topical OintmentSCD1
725145petrolatum 41 % Topical OintmentSY1

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130616784146317GTIN-13: 0616784146317
EAN-13: 0616784146317
GTIN-12: 616784146317
UPC-A: 616784146317
GTIN storage (14 digits): 00616784146317		1463_IN_MASTER_R2500908-1.jpg
BarcodeEAN-130616784146416GTIN-13: 0616784146416
EAN-13: 0616784146416
GTIN-12: 616784146416
UPC-A: 616784146416
GTIN storage (14 digits): 00616784146416		1464_IN_ MASTER_R250908-1.jpg
BarcodeEAN-130616784146522GTIN-13: 0616784146522
EAN-13: 0616784146522
GTIN-12: 616784146522
UPC-A: 616784146522
GTIN storage (14 digits): 00616784146522		1465_BX_MASTER_R250908-1.jpg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67777-555-01AquaSoothe106 g in 1 TUBEOINTMENT1061
67777-555-02AquaSoothe24 in 1 CASEOINTMENT241
67777-555-03AquaSoothe396.9 g in 1 JAROINTMENT396.91
67777-555-04AquaSoothe12 in 1 CASEOINTMENT121
67777-555-05AquaSoothe0.9 g in 1 PACKETOINTMENT0.91
67777-555-05AquaSoothe144 in 1 BOXOINTMENT1441
67777-555-06AquaSoothe12 in 1 CASEOINTMENT121

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67777-555-01GM - Gram67777-5557d95612f-11fb-4d15-b3a5-0bcfb61cf42212026-05-22
67777-555-02GM - Gram67777-5555367718f-17a0-4c08-a67f-b4cadb13e4b312026-05-22
67777-555-03GM - Gram67777-555d9b396fa-137d-4055-9b67-4a5d73d0962212026-05-22
67777-555-04GM - Gram67777-555f2d93837-49d4-4dee-b470-d50af372b32312026-05-22

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
67777-55567777-555-05, 67777-555-06, 67777-555-03, 67777-555-04, 67777-555-01, 67777-555-02

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
MINERAL OILT5L8T28FGPIACT
LANOLIN ALCOHOLS884C3FA9HEIACT
DEXPANTHENOL1O6C93RI7ZIACT
GLYCERINPDC6A3C0OXIACT
PETROLATUM4T6H12BN9UACTIB
CERESINQ1LS2UJO3AIACT

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
AquaSootheAQUASOOTHEDynarex Corporation45878c3c-d05d-984c-e063-6294a90a46612025-12-09WarningsExact identifier
ndc (package): 67777-555-01
ndc (package): 67777-555-04
ndc (package): 67777-555-03
ndc (package): 67777-555-06
ndc (package): 67777-555-05
ndc (package): 67777-555-02
ndc (product): 67777-555
ndc11 (package): 67777055504
ndc11 (package): 67777055503
ndc11 (package): 67777055502
ndc11 (package): 67777055501
ndc11 (package): 67777055505
ndc11 (package): 67777055506
spl id: 45878c3c-d05e-984c-e063-6294a90a4661
spl set id: 45878c3c-d05d-984c-e063-6294a90a4661

Reported adverse events (FAERS/openFDA)#

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