Flurandrenolide (Page 2 of 2)

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
Itching
Irritation
Dryness
Folliculitis
Hypertrichosis
Acneform eruptions
Hypopigmentation
Perioral dermatitis
Allergic contact dermatitis

The following may occur more frequently with occlusive dressings:

Maceration of the skin
Secondary infection
Skin atrophy
Striae
Miliaria

To report SUSPECTED ADVERSE REACTIONS , contact Teligent Pharma, Inc. at 1-856-697-1441, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Postmarketing Adverse Reactions

The following adverse reactions have been identified during post approval use of flurandrenolide, USP. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Skin: skin striae, hypersensitivity, skin atrophy, contact dermatitis and skin discoloration.

OVERDOSAGE

Topically applied corticosteroids can be absorbed in sufficient amounts to produce systemic effects (see PRECAUTIONS).

DOSAGE AND ADMINISTRATION

For dry, scaly lesions, the ointment is applied as a thin film to affected areas 2 or 3 times daily.

Therapy should be discontinued when control is achieved. If no improvement is seen within 2 weeks, reassessment of the diagnosis may be necessary.

Flurandrenolide ointment should not be used with occlusive dressings unless directed by a physician. Tight-fitting diapers or plastic pants may constitute occlusive dressings.

HOW SUPPLIED

Flurandrenolide Ointment USP, 0.05% is available as follows:

NDC 52565-017-15 15 gram tubes
NDC 52565-017-30 30 gram tubes
NDC 52565-017-60 60 gram tubes

Keep out of reach of children.

Storage

Keep tightly closed.
Protect from light.
Store at 20° to 25°C (68° to 77°F) with excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]

Teligent Pharma, Inc.
Buena, New Jersey 08310
Rev. 05/16

PRINCIPAL DISPLAY PANEL — 15 Gram Carton

Flurandrenolide
Ointment USP, 0.05%
Net Wt. 15 grams
Rx only
For External Use Only
Not For Use In The Eyes

15 g carton PDP
(click image for full-size original)
FLURANDRENOLIDE flurandrenolide ointment
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:52565-017
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Flurandrenolide (Flurandrenolide) Flurandrenolide 0.5 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
White Wax
Cetyl Alcohol
Sorbitan Sesquioleate
Petrolatum
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:52565-017-15 1 TUBE in 1 CARTON contains a TUBE
1 15 g in 1 TUBE This package is contained within the CARTON (52565-017-15)
2 NDC:52565-017-30 1 TUBE in 1 CARTON contains a TUBE
2 30 g in 1 TUBE This package is contained within the CARTON (52565-017-30)
3 NDC:52565-017-60 1 TUBE in 1 CARTON contains a TUBE
3 60 g in 1 TUBE This package is contained within the CARTON (52565-017-60)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA207851 12/30/2016
Labeler — Teligent Pharma, Inc. (011036910)
Registrant — Teligent Pharma, Inc. (011036910)
Establishment
Name Address ID/FEI Operations
Teligent Pharma, Inc. 011036910 manufacture (52565-017)

Revised: 12/2016 Teligent Pharma, Inc.

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