AQUAX-H- hydrocortisone butyrate cream 
Pella Pharmaceuticals Co. ltd

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.




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.


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.


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


Do not use Aquax-H ® Cream


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

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


Be extra careful with Aquax-H ® Cream


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.


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

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

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.


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

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.


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

How Supplied

30 g packs


Primary Package

Primary Package

Secondary Package

Secondary Package

hydrocortisone butyrate cream
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:82160-127
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Product Characteristics
FlavorImprint Code
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:82160-127-011 in 1 CARTON03/16/2015
130 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other03/16/2015
Labeler - Pella Pharmaceuticals Co. ltd (562370925)

Revised: 12/2023
Document Id: 0d6d72e1-ce60-2564-e063-6394a90af4fe
Set id: d042d188-4afc-af1d-e053-2a95a90a386c
Version: 130
Effective Time: 20231226
Pella Pharmaceuticals Co. ltd