Composition
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.
The following Structured Product Label (SPL) was submitted to the FDA by Pella Pharmaceuticals Co. Ltd for the product Aquax-h (NDC 82160-127). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding composition, properties, indications, contraindications, precautions, drug interactions, warnings, pregnancy, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
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.
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.
There is nothing known about Aquax-H ®Cream and the ability to drive or to use machines. However, no effects are to be expected.
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.
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.
30 g packs
* Please review the disclaimer below.