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

Acneiform 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

Postmarketing Adverse Reactions

The following adverse reactions have been identified during post approval use of flurandrenolide lotion. 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

Shake well before using. A small quantity of Flurandrenolide Lotion USP, 0.05% should be rubbed gently into the affected area 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 Lotion USP, 0.05% 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 Lotion USP, 0.05% is supplied in plastic squeeze bottles as follows:

120 mL (NDC 63629-8657-1)

Keep out of reach of children.

Storage: Avoid freezing. 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].

Rx Only

Flurandrenolide 0.05% Lotion, #120

Label
(click image for full-size original)
FLURANDRENOLIDE
flurandrenolide lotion
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63629-8657(NDC:45802-928)
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FLURANDRENOLIDE (FLURANDRENOLIDE) FLURANDRENOLIDE 0.5 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN
CETYL ALCOHOL
STEARIC ACID
GLYCERYL MONOSTEARATE
MINERAL OIL
POLYOXYL 40 STEARATE
MENTHOL, UNSPECIFIED FORM
BENZYL ALCOHOL
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:63629-8657-1 1 BOTTLE, PLASTIC in 1 CARTON contains a BOTTLE, PLASTIC
1 120 mL in 1 BOTTLE, PLASTIC This package is contained within the CARTON (63629-8657-1)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA207133 10/06/2016
Labeler — Bryant Ranch Prepack (171714327)
Registrant — Bryant Ranch Prepack (171714327)
Establishment
Name Address ID/FEI Operations
Bryant Ranch Prepack 171714327 REPACK (63629-8657), RELABEL (63629-8657)

Revised: 04/2022 Bryant Ranch Prepack

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