Clobetasol Propionate Cream (Page 2 of 2)

ADVERSE REACTIONS

In controlled clinical trials, the most frequent adverse reactions reported for clobetasol propionate cream were burning and stinging sensation in 1% of treated patients. Less frequent adverse reactions were itching, skin atrophy, and cracking and fissuring of the skin.

Cushing syndrome has been reported in infants and adults as a result of prolonged use of topical clobetasol propionate formulations.

The following additional local adverse reactions have been reported with topical corticosteroids, and they may occur more frequently with the use of occlusive dressings and higher potency corticosteroids. These reactions are listed in an approximately decreasing order of occurrence: dryness, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, irritation, striae, and 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.

OVERDOSAGE

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

DOSAGE AND ADMINISTRATION

Apply a thin layer of clobetasol propionate cream to the affected skin areas twice daily and rub in gently and completely (see INDICATIONS AND USAGE).


Clobetasol propionate cream is a super-high potency topical corticosteroid; therefore, treatment should be limited to 2 consecutive weeks and amounts greater than 50 g/week should not be used.

As with other highly active corticosteroids, therapy should be discontinued when control has been achieved. If no improvement is seen within 2 weeks, reassessment of diagnosis may be necessary.

Clobetasol propionate cream should not 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 cream, safety did not differ from that in younger patients; therefore, no dosage adjustment is recommended.

HOW SUPPLIED

Clobetasol Propionate Cream USP, 0.05% is supplied in tubes containing:

60 gram tube NDC 70512-028-60


Store cream between 15° and 30°C (59° and 86°F).


Clobetasol propionate cream should not be refrigerated. Do not use if you see separation into a liquid and semi-solid state.


Rx only


Manufactured for:
Sola Pharmaceuticals
Baton Rouge, LA 70809


C101454
Revised: 02/2020

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

60 gram Carton

NDC: 70512-028-60


Clobetasol Propionate
Cream USP, 0.05%


FOR DERMATOLOGIC USE ONLY. NOT FOR OPHTHALMIC USE.

60grams

Rx Only

tube
(click image for full-size original)
carton
(click image for full-size original)

CLOBETASOL PROPIONATE CREAM clobetasol propionate cream cream
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70512-028
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 g
Inactive Ingredients
Ingredient Name Strength
CETYL ALCOHOL
ANHYDROUS CITRIC ACID
GLYCOL STEARATE
LANOLIN
PEG-8 STEARATE
METHYLPARABEN
POLYSORBATE 60
PROPYLENE GLYCOL
PROPYLPARABEN
WATER
SODIUM CITRATE
STEARYL ALCOHOL
PETROLATUM
SODIUM HYDROXIDE
Product Characteristics
Color white Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70512-028-60 1 TUBE in 1 CARTON contains a TUBE
1 60 g in 1 TUBE This package is contained within the CARTON (70512-028-60)
2 NDC:70512-028-15 1 TUBE in 1 CARTON contains a TUBE
2 15 g in 1 TUBE This package is contained within the CARTON (70512-028-15)
3 NDC:70512-028-30 1 TUBE in 1 CARTON contains a TUBE
3 30 g in 1 TUBE This package is contained within the CARTON (70512-028-30)
4 NDC:70512-028-45 1 TUBE in 1 CARTON contains a TUBE
4 45 g in 1 TUBE This package is contained within the CARTON (70512-028-45)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA209974 02/04/2019
Labeler — Sola Pharmaceuticals (080121345)

Revised: 01/2021 Sola Pharmaceuticals

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