Fluocinolone Acetonide .1 mg/mL
Fluocinolone Acetonide · SOLUTION · Lupin Pharmaceuticals,Inc.
Fluocinolone Acetonide is a solution containing fluocinolone acetonide at .1 mg/mL, taken topical. Manufactured by Lupin Pharmaceuticals,Inc..
Key Facts
- Brand Name
- Fluocinolone Acetonide
- Generic Name
- Fluocinolone Acetonide
- NDC Code (Product)
43386-069- Manufacturer
- Lupin Pharmaceuticals,Inc.
- Strength
- .1 mg/mL
- Dosage Form
- SOLUTION
- Route
- TOPICAL
- Marketing Status
- Application #
- ANDA206422
- Drug Class
- Corticosteroid [EPC]
- Marketing Start
- 09/02/2015
Recall History
MasterPharm LLC
Lack of Processing Controls (lack of assurance of conformity to specifications).
LUPIN SOMERSET
Failed Impurities/Degradation Specifications:Out of specification result noticed for total impurities observed during stability analysis
Hill Dermaceuticals, Inc.
Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine testing.
Hill Dermaceuticals, Inc.
Subpotent; fluocinolone acetonide
Hill Dermaceuticals, Inc.
Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine testing.
Hill Dermaceuticals, Inc.
Subpotent; 22 month stability timepoint
Hill Dermaceuticals, Inc.
Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine testing.
SUN PHARMACEUTICAL INDUSTRIES INC
Failed Impurities/Degradation Specifications: Out of specification result was obtained for the known impurity D.
Hill Dermaceuticals, Inc.
Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine testing.
Lyne Laboratories, Inc.
Subpotent Drug
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
INDICATIONS AND USAGE Fluocinolone Acetonide Topical Solution is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.
Dosage & Administration
DOSAGE AND ADMINISTRATION Fluocinolone Acetonide Solution is generally applied to the affected area as a thin film from two to four times daily depending on the severity of the condition. In hairy sites, the hair should be parted to allow direct contact with the lesion. Occlusive dressing may be used for the management of psoriasis or recalcitrant conditions. If an infection develops, the use of occlusive dressings should be discontinued and appropriate antimicrobial therapy instituted.
Contraindications
CONTRAINDICATIONS Topical corticosteroids are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.
Adverse Reactions
ADVERSE REACTIONS The following local adverse reactions are reported infrequently with topical corticosteroids, but may occur more frequently with the use of occlusive dressings. These reactions are listed in an approximate decreasing order of occurrence: Burning Perioral dermatitis Itching Allergic contact dermatitis Irritation Maceration of the skin Dryness Secondary infection Folliculitis Skin atrophy Hypertrichosis Striae Acneiform eruptions Miliaria Hypopigmentation
Frequently Asked Questions
What is Fluocinolone Acetonide used for?
Fluocinolone Acetonide contains Fluocinolone Acetonide. It is a solution taken topical. Consult your doctor for specific uses.
Is Fluocinolone Acetonide a controlled substance?
Fluocinolone Acetonide is not classified as a controlled substance by the DEA.
What is the generic name for Fluocinolone Acetonide?
The generic name for Fluocinolone Acetonide is Fluocinolone Acetonide. There are 8 other brand versions of Fluocinolone Acetonide.
What is the NDC code for Fluocinolone Acetonide .1 mg/mL?
The NDC (National Drug Code) for Fluocinolone Acetonide .1 mg/mL is 43386-069, listed by Lupin Pharmaceuticals,Inc..