Aquax-H

Manufacturer
Pella Pharmaceuticals Co. ltd
Effective date
2024-12-31
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
131
Source
full-release
Hydrated at
2026-05-31 21:21:17

Label at a glance#

ProductAquax-H
Active ingredientHYDROCORTISONE BUTYRATE
Label structure15 sections

Dosage and administration

Apply Aquax-H ® Cream thinly to the affected skin area and massage lightly into the skin. Do not apply more often than 1-3 times daily unless your doctor has advised otherwise. When your symptoms have receded, your doctor may decide that you can use the cream less often. In general, you should not use more than 1 to 2 tubes per week. What you can expect when treatment has been stopped The original symptoms can rea...

Storage and handling

Store below 25 °C Do not store in a refrigerator or freezer.

Label contents#

Full prescribing information#

Composition

COMPONENTS

Each 1 g contains: Hydrocortisone 17-Butyrate 1 mg.
Excipients: Petrolatum, Cetearyl Alcohol, Mineral Oil, Ceteareth-20, Benzyl Alcohol, Citric Acid, Sodium Citrate, Propylparaben and Purified Water.

Properties

DESCRIPTION SECTION

Aquax-H ® Cream contains a corticosteroid and quickly suppresses symptoms of certain skin conditions such as itching, redness and scaling. Corticosteroids don't generally remove the cause of the symptoms. The Aquax-H ® Cream base ensures that the skin condition becomes less moist.

Indications

INDICATIONS & USAGE SECTION

Aquax-H ® Cream can be used for the treatment of superficial skin conditions where itching, redness and scaling are often present.

Contraindications

CONTRAINDICATIONS SECTION

Do not use Aquax-H ® Cream

  • If your skin condition is caused by infections with bacteria, viruses, fungi, yeasts or parasites as these could either be made worse or become unnoticeable.
  • In acne even if the skin is red.
  • For wounds or scaly skin (ichthyosis).
  • If your skin condition is the result of earlier treatment with corticosteroids such as inflammation of the skin around the mouth or thin skin possibly with streaks and vulnerable blood vessels.
  • For childhood rash on the foot sole.
  • If you are hypersensitive to hydrocortisone 17-butyrate or to any of the excipients (uncommon).

Precautions

PRECAUTIONS SECTION

Aquax-H ® Cream contains certain excipients like Cetearyl Alcohol that in rare cases can cause hypersensitivity reactions ( itching, red spots) of the skin.

Drug Interactions

DRUG INTERACTIONS SECTION

Inform your doctor or pharmacist if you are using other medicines or have used them in the recent past. This also applies to medicines you have obtained without a prescription

Warnings

WARNINGS SECTION

Be extra careful with Aquax-H ® Cream

  • If you want to treat the facial skin, genital skin and skin folds as these areas of skin are particularly sensitive to corticosteroids.
  • If you apply the cream under an occlusive bandage, to large areas of skin or are treating a child in which cases you should be under the control of your doctor.
  • The Aquax-H ® Cream should not be introduced into the eye or applied to the eyelids.
  • The application of corticosteroids for long periods in children should be avoided.
  • Consult your doctor if any of the above warnings apply to you.

Pregnancy

PREGNANCY SECTION

Ask your doctor or pharmacist for advice before using a medical product. If you want to apply the cream during pregnancy then discuss this with your doctor.

Breast-feeding

LACTATION SECTION

Ask your doctor or pharmacist for advice before using a medical product. If you want to apply the Aquax-H ® during breast-feeding then discuss this with your doctor.

Driving and the use of machines

OTHER SAFETY INFORMATION

There is nothing known about Aquax-H ® Cream and the ability to drive or to use machines. However, no effects are to be expected.

Dosage and Administration

DOSAGE & ADMINISTRATION SECTION

Apply Aquax-H ® Cream thinly to the affected skin area and massage lightly into the skin. Do not apply more often than 1-3 times daily unless your doctor has advised otherwise.
When your symptoms have receded, your doctor may decide that you can use the cream less often. In general, you should not use more than 1 to 2 tubes per week.
What you can expect when treatment has been stopped
The original symptoms can reappear if treatment is stopped prematurely.
Always consult you doctor or pharmacist before stopping treatment.

Overdosage

OVERDOSAGE SECTION

What you should do if you have used too much Aquax-H Cream
Contact you doctor or pharmacist if you have used too much Aquax-H ® Cream.
What you should do if you have forgotten to use Aquax-H Cream
If you have forgotten to apply it a single time just carry on as before. There is no need to compensate for a missed application.

Side Effects

ADVERSE REACTIONS SECTION

Aquax-H ® Cream can cause side effects just like all medicines.
You could sometimes have a burning or prickly feeling at the site of application but this is mostly not serious and disappears on its own.
If you have used it for prolonged periods or under an occlusive bandage, you could get a rash, pimples or the formation of pus. The skin could become discolored or thin, sometimes with stripes.
Consult your doctor if you have any of these side effects.
Also consult your doctor or pharmacist if you either have any side effects not mentioned in this leaflet or any others that you think might be serious.

Storage

STORAGE AND HANDLING SECTION

Store below 25 °C
Do not store in a refrigerator or freezer.

How Supplied

HOW SUPPLIED SECTION

30 g packs

THIS IS A MEDICAMENT

GENERAL PRECAUTIONS SECTION

  • Medicament is a product which affects your health and its consumption contrary to instructions is dangerous for you.
  • Strictly follow the doctor's prescription, the method of use and the instruction of the pharmacist who sold the medicament.
  • The doctor and the pharmacist are experts in medicine, its benefits and risks.
  • Do not by yourself interrupt the period of treatment prescribed for you.
  • Do not repeat the same prescription without consulting your doctor.
  • Keep medicament out of reach of children.

Primary Package

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Primary PackagePrimary Package

Secondary Package

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Secondary PackageSecondary Package

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1370770hydrocortisone butyrate 0.1 % Topical CreamPSN131
1370770hydrocortisone butyrate 1 MG/ML Topical CreamSCD131
1370770hydrocortisone butyrate 0.1 % Topical CreamSY131

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
HYDROCORTISONE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
15bd4439-874a-4934-9954-248e5455d460Product name120260310
9962b773-9f2e-22cc-0032-535e48ac417bProduct name320250724
56bb0587-1bf2-48b2-9d93-fc9f59d1eeb2Product name120250325
4d56e8eb-d741-d4a5-de3f-2bab1af75a60Product name720220608
626d7260-31b5-4412-84fd-579746adb6b3Product name120210513
8a011600-5e61-4c59-ab7b-54ab658a3b71Product name220181127
a919621a-248d-3c7a-1084-9f9ce286fdfdProduct name220181009
e7d5a174-836b-a0af-b014-cb0826c69ddcProduct name220181004
fcce390d-6460-4701-87cf-940d8800a1c3Product name220180212
bf065fa6-1e3b-e4c3-0bde-2dc842ceeea1Product name220150218
02657a3f-1489-66ea-f740-5ab9524e57d7Product name120140508
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36fdc54c-bbeb-981e-8a53-4d768e283892Product name120140508
58f3f9b7-3b9b-a9c1-1c9f-18ac777192b8Product name120140508
61e59a42-186b-9f4b-aec3-fb49a6debc31Product name120140508
705740e1-dee5-2610-c5a3-4c59cd9d62afProduct name120140508
7bdc4804-3832-c0df-e519-72b6d47c9792Product name120140508
a7051cba-790b-a699-81f8-dbbbdbd9b5acProduct name120140508
abaf203f-619e-f265-559f-8c81af5cb1c2Product name120140508
acc4d8bb-0e29-e9f8-65f8-31e94184a9c0Product name120140508
b045ad64-0f28-9a02-2f9b-b34d94fb2278Product name120140508
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fe21f3fd-a378-0654-1972-db3c3b64470eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82160-127-01Aquax-H30 g in 1 TUBECREAM30131
82160-127-01Aquax-H1 in 1 CARTONCREAM1131

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82160-127AQUAX-H (HYDROCORTISONE BUTYRATE) CREAM [PELLA PHARMACEUTICALS CO. LTD]131Legacy NDC, 2 package rows20250101_d042d188-4afc-af1d-e053-2a95a90a386c.zip

Products#

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

DailyMed product names page 1 of 1 · 3 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
82160-12782160-127-01

Ingredients#

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

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

Name, UNII, Kind table
NameUNIIKind
HYDROCORTISONE BUTYRATE05RMF7YPWNACTIB

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
2a912c1b-7041-e496-e063-6294a90a532cd042d188-4afc-af1d-e053-2a95a90a386c2024-12-31Warnings, Adverse reactionsExact identifier
spl id: 2a912c1b-7041-e496-e063-6294a90a532c
spl set id: d042d188-4afc-af1d-e053-2a95a90a386c

Reported adverse events (FAERS/openFDA)#

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