CLOBETASOL PROPIONATE (Page 2 of 2)

ADVERSE REACTIONS

Clobetasol propionate topical solution is generally well tolerated when used for 2-week treatment periods.

The most frequent adverse events reported for clobetasol propionate topical solution have been local and have included burning and/or stinging sensation, which occurred in 29 of 294 patients; scalp pustules, which occurred in 3 of 294 patients; and tingling and folliculitis, each of which occurred in 2 of 294 patients. Less frequent adverse events were itching and tightness of the scalp, dermatitis, tenderness, headache, hair loss, and eye irritation, each of which occurred in 1 of 294 patients.

The following local adverse reactions are reported infrequently when topical corticosteroids are used as recommended. These reactions are listed in an approximately decreasing order of occurrence: burning, itching, irritation, dryness, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, maceration of the skin, secondary infection, skin atrophy, striae, and miliaria. Systemic absorption of topical corticosteroids has produced reversible HPA axis suppression, manifestations of Cushing’s syndrome, hyperglycemia, and glucosuria in some patients. In rare instances, treatment (or withdrawal of treatment) of psoriasis with corticosteroids is thought to have exacerbated the disease or provoked the pustular form of the disease, so careful patient supervision is recommended.

To report SUSPECTED ADVERSE REACTIONS, contact Saptalis Pharmaceuticals, LLC at 1-833-727-8254 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

OVERDOSAGE

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

DOSAGE AND ADMINISTRATION

Clobetasol propionate topical solution should be applied to the affected scalp areas twice daily, once in the morning and once at night.

Clobetasol propionate topical solution is potent; therefore, treatment must be limited to 2 consecutive weeks and amounts greater than 50 mL/week should not be used.

Clobetasol propionate topical solution is not to be used with occlusive dressings.

Geriatric Use

In studies where geriatric patients (65 years of age or older, see PRECAUTIONS) have been treated with clobetasol propionate topical solution, safety did not differ from that in younger patients; therefore, no dosage adjustment is recommended.

HOW SUPPLIED

Clobetasol propionate topical solution, USP 0.05% is a clear, colorless liquid supplied in plastic squeeze bottles, 25 mL (NDC 42571-362-81) and 50 mL (NDC 42571-362-99).

Store at 20° to 25°C (68° to 77°F), with excursions permitted between 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Do not refrigerate. Keep tightly closed.

Do not use near an open flame.

Distributed by:
Micro Labs USA, Inc.
Somerset, NJ 08873

Manufactured by:
Saptalis Pharmaceuticals, LLC
Hauppauge, NY 11788

Revised: January 2022-R2

Package/Label Display Panel — 25 mL Label

NDC 42571-362-81

Clobetasol Propionate Topical Solution, USP

0.05%

SCALP APPLICATION

For Dermatologic Use Only–
Not for Ophthalmic Use.

Rx only

25 mL

Package/Label Display Panel — 25 mL Carton

NDC 42571-362-81

Clobetasol Propionate Topical Solution, USP

0.05%

SCALP APPLICATION

For Dermatologic Use Only–
Not for Ophthalmic Use.

Rx only

25 mL

Package/Label Display Panel — 50 mL Label

NDC 42571-362-99

Clobetasol Propionate Topical Solution, USP

0.05%

SCALP APPLICATION

For Dermatologic Use Only–
Not for Ophthalmic Use.

Rx only

50 mL

Package/Label Display Panel — 50 mL Carton

NDC 42571-362-99

Clobetasol Propionate Topical Solution, USP

0.05%

SCALP APPLICATION

For Dermatologic Use Only–
Not for Ophthalmic Use.

Rx only

50 mL

CLOBETASOL PROPIONATE clobetasol propionate solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42571-362 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CLOBETASOL PROPIONATE (CLOBETASOL) CLOBETASOL PROPIONATE 0.5 mg in 1 mL

Inactive Ingredients Ingredient Name Strength CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) ISOPROPYL ALCOHOL SODIUM HYDROXIDE WATER

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:42571-362-81 1 BOTTLE in 1 CARTON contains a BOTTLE 1 25 mL in 1 BOTTLE This package is contained within the CARTON (42571-362-81) 2 NDC:42571-362-99 1 BOTTLE in 1 CARTON contains a BOTTLE 2 50 mL in 1 BOTTLE This package is contained within the CARTON (42571-362-99)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA211494 10/02/2019

Labeler — Micro Labs Limited (862174955)

Registrant — Saptalis Pharmaceuticals, LLC (080145868)

Establishment
Name	Address	ID/FEI	Operations
Saptalis Pharmaceuticals, LLC		080145868	MANUFACTURE (42571-362)

Revised: 01/2022 Micro Labs Limited