Aquax-h
Hydrocortisone Butyrate
Pella Pharmaceuticals Co. Ltd
Human Prescription Drug
NDC 82160-127Aquax-h also known as Hydrocortisone Butyrate is a human prescription drug labeled by 'Pella Pharmaceuticals Co. Ltd'. National Drug Code (NDC) number for Aquax-h is 82160-127. This drug is available in dosage form of Cream. The names of the active, medicinal ingredients in Aquax-h drug includes Hydrocortisone Butyrate - 30 mg/30g . The currest status of Aquax-h drug is Active.
Drug Information:
| Drug NDC: | 82160-127 |
| The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC. |
| Proprietary Name: | Aquax-h |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Product Type: | Human Prescription Drug |
| Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing. |
| Non Proprietary Name: | Hydrocortisone Butyrate |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Pella Pharmaceuticals Co. Ltd |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Cream |
| The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources. |
| Status: | Active |
| FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved. |
| Substance Name: | HYDROCORTISONE BUTYRATE - 30 mg/30g
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | TOPICAL
|
| The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
Marketing Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Marketing Category: | UNAPPROVED DRUG OTHER |
| Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (ANDA), BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
| Marketing Start Date: | 16 Mar, 2015 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 21 Dec, 2025 |
| This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached. |
| Listing Expiration Date: | 31 Dec, 2024 |
| This is the date when the listing record will expire if not updated or certified by the firm. |
OpenFDA Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Manufacturer Name: | Pella Pharmaceuticals Co. ltd
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 1370770
|
| The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms. |
| Original Packager: | Yes
|
| Whether or not the drug has been repackaged for distribution. |
| UNII: | 05RMF7YPWN
|
| Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information. |
| Pharmacologic Class: | Corticosteroid Hormone Receptor Agonists [MoA]
Corticosteroid [EPC]
|
| These are the reported pharmacological class categories corresponding to the SubstanceNames listed above. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 82160-127-01 | 1 TUBE in 1 CARTON (82160-127-01) / 30 g in 1 TUBE | 16 Mar, 2015 | N/A | No |
| Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together. |
Product Elements:
Aquax-h hydrocortisone butyrate hydrocortisone butyrate hydrocortisone
Drug Interactions:
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
Indications and Usage:
Indications aquax-h ® cream can be used for the treatment of superficial skin conditions where itching, redness and scaling are often present.
Warnings:
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. breast-feeding 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
Read more... ® cream and the ability to drive or to use machines. however, no effects are to be expected.
General Precautions:
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.
Dosage and Administration:
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.
Contraindications:
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).
Adverse Reactions:
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.
Drug Interactions:
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
Use in Pregnancy:
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.
Overdosage:
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.
Description:
Properties 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.
How Supplied:
How supplied 30 g packs
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