Prescription Drug Information: Clobetasol Propionate (Page 2 of 2)

OVERDOSAGE

Topically applied Clobetasol Propionate Topical Solution, 0.05% can be absorbed in sufficient amounts to produce systemic effects (see PRECAUTIONS).

DOSAGE AND ADMINISTRATION

Clobetasol Propionate Topical Solution, 0.05% should be applied to the affected scalp areas twice daily, once in the morning and once at night.

Clobetasol Propionate Topical Solution, 0.05% 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, 0.05% 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 USP, 0.05%, 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 supplied in plastic squeeze bottles, 25 mL (NDC 63646-500-25) and 50 mL (NDC 63646-500-50).

Store between 39° and 77°F (4° and 25°C). Do not use near an open flame.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Manufactured and Distributed by:
Tolmar, Inc.
Fort Collins, CO 80526

04006047 Rev. 2 09/19

PRINCIPAL DISPLAY PANEL

50 mL bottle front
(click image for full-size original)
50 mL bottle back
(click image for full-size original)
50 mL carton
(click image for full-size original)
CLOBETASOL PROPIONATE
clobetasol propionate solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63646-500
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 934
ISOPROPYL ALCOHOL
WATER
SODIUM HYDROXIDE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:63646-500-25 1 BOTTLE in 1 CARTON contains a BOTTLE
1 25 mL in 1 BOTTLE This package is contained within the CARTON (63646-500-25)
2 NDC:63646-500-50 1 BOTTLE in 1 CARTON contains a BOTTLE
2 50 mL in 1 BOTTLE This package is contained within the CARTON (63646-500-50)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076977 02/08/2017
Labeler — TOLMAR Inc. (791156578)
Establishment
Name Address ID/FEI Operations
TOLMAR 1201 Cornerstone LLC 079112310 ANALYSIS (63646-500), LABEL (63646-500), MANUFACTURE (63646-500), PACK (63646-500)
Establishment
Name Address ID/FEI Operations
TOLMAR Inc. 791156578 ANALYSIS (63646-500), LABEL (63646-500), MANUFACTURE (63646-500), PACK (63646-500)

Revised: 09/2020 TOLMAR Inc.

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