FDA.reportPublic FDA data

Aquax

Manufacturer
Pella Pharmaceuticals Co. Ltd
Effective date
2021-11-22
Label type
HUMAN OTC DRUG LABEL
Version
214
Source
legacy-cache
Hydrated at
2026-08-01 22:25:44

Label at a glance#

ProductAquax
Active ingredientPETROLATUM, MINERAL OIL
Label structure14 sections

Dosage and administration

Apply Aquax ® Cream on the skin and spread it well, it will help the skin to offset the loss of natural oils caused by washing, and prevents irritation that soap can cause to the skin. Aquax ® Cream can be used as often as needed.

Storage and handling

Store at a temperature below 30 ° C

Label contents#

Full prescribing information#

Forms and presentation

HOW SUPPLIED SECTION

Cream: Tube of 150 g

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Mineral Oil

Petrolatum

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Aqua, Glycerin, Cetearyl Alcohol, Ceteareth-22, Ceteareth-25, Polysorbate 80, Bis-PEG / PPG-16/16 PEG / PPG 16/16 Dimethicone; Caprylic/Capric Triglyceride, Sodium Citrate, Methylparaben, Citric Acid, Propylparaben.

Purpose

OTC - PURPOSE SECTION

Moisturizer

Properties

DESCRIPTION SECTION

Aquax ® Cream is an emollient and moisturizer that nourishes the skin.

Indications

INDICATIONS & USAGE SECTION

Aquax ® Cream is used for dry and sensitive skin, in case of eczema and other similar skin problems; Aquax ® Cream helps prevent further water loss from the skin, preventing thereby skin dryness and reduces roughness, relieves itching and gives a sensation of comfort.

Contraindications

CONTRAINDICATIONS SECTION

Hypersensitivity to any of the components.

Side effects

ADVERSE REACTIONS SECTION

Aquax ® Cream has no known side effect, because using it is safe for all members of the Family, Children and Adults.

Dosage and Administration

DOSAGE & ADMINISTRATION SECTION

Apply Aquax ® Cream on the skin and spread it well, it will help the skin to offset the loss of natural oils caused by washing, and prevents irritation that soap can cause to the skin.
Aquax ® Cream can be used as often as needed.

Precaution

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children

Warnings

WARNINGS SECTION

  • For external use only
  • If you are allergic to any of the ingredients, you should check with your doctor or pharmacist before you use the product.
  • Avoid contact with eyes

Storage conditions

STORAGE AND HANDLING SECTION

Store at a temperature below 30 ° C

Primary Package

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Primary PackagePrimary Package

Secondary Package

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Secondary PackageSecondary Package

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
82160-214-012025-01-28C16284748780-1f386c649-ef93-0266-e053-dadaa90a7c1aAquax

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
82160-21482160-214-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
CETEARETH-258FA93U5T67IACT
CETEARETH-2228VZG1E234IACT
METHYLPARABENA2I8C7HI9TIACT
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
WATER059QF0KO0RIACT
PETROLATUM4T6H12BN9UACTIB
POLYSORBATE 806OZP39ZG8HIACT
MINERAL OILT5L8T28FGPACTIB
GLYCERINPDC6A3C0OXIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
SODIUM CITRATE1Q73Q2JULRIACT
PROPYLPARABENZ8IX2SC1OHIACT
BIS-PEG/PPG-16/16 PEG/PPG-16/16 DIMETHICONE55A74AJ3KBIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT

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
2c3489aa-6690-2ea9-e063-6294a90ab012d15eaed9-f0e6-65f1-e053-2995a90a774a2025-01-21Warnings, Adverse reactionsExact identifier
spl set id: d15eaed9-f0e6-65f1-e053-2995a90a774a

Reported adverse events (FAERS/openFDA)#

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