Label: AQUAX-H- hydrocortisone butyrate cream
- NDC Code(s): 82160-127-01
- Packager: Pella Pharmaceuticals Co. ltd
- Category: HUMAN PRESCRIPTION DRUG LABEL
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.
Drug Label Information
Updated December 26, 2023
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- Official Label (Printer Friendly)
- Composition
- Properties
- Indications
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Contraindications
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
- Drug Interactions
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Warnings
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
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.
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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. -
Overdosage
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. - Storage
- How Supplied
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THIS IS A MEDICAMENT
- 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
- Secondary Package
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INGREDIENTS AND APPEARANCE
AQUAX-H
hydrocortisone butyrate creamProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:82160-127 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HYDROCORTISONE BUTYRATE (UNII: 05RMF7YPWN) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE BUTYRATE 30 mg in 30 g Product Characteristics Color white Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:82160-127-01 1 in 1 CARTON 03/16/2015 1 30 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 03/16/2015 Labeler - Pella Pharmaceuticals Co. ltd (562370925)