CLOBETASOL PROPIONATE cream

Country: Amerika Syarikat

Bahasa: Inggeris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

CLOBETASOL PROPIONATE (UNII: 779619577M) (CLOBETASOL - UNII:ADN79D536H)

Boleh didapati daripada:

Zydus Lifesciences Limited

Laluan pentadbiran:

TOPICAL

Jenis preskripsi:

PRESCRIPTION DRUG

Tanda-tanda terapeutik:

Clobetasol propionate cream is super-high potency corticosteroid formulations indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. Treatment beyond 2 consecutive weeks is not recommended, and the total dosage should not exceed 50 g/week because of the potential for the drug to suppress the hypothalamic-pituitary-adrenal (HPA) axis. Use in pediatric patients under 12 years of age is not recommended. 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 the diagnosis may be necessary. Clobetasol propionate cream, 0.05% is contraindicated in those patients with a history of hypersensitivity to any of the components of the preparations.

Ringkasan produk:

Clobetasol Propionate Cream USP, 0.05% is white to off-white cream supplied in: NDC 70771-1442-1 in tube of 15 g NDC 70771-1442-2 in tube of 30 g NDC 70771-1442-4 in tube of 45 g NDC 70771-1442-3 in tube of 60 g

Status kebenaran:

Abbreviated New Drug Application

Ciri produk

CLOBETASOL PROPIONATE - CLOBETASOL PROPIONATE CREAM
ZYDUS LIFESCIENCES LIMITED
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CLOBETASOL PROPIONATE CREAM USP, 0.05%
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
NDC 70771-1442-1
Clobetasol Propionate Cream USP, 0.05%
Rx only
15 g
CLOBETASOL PROPIONATE
clobetasol propionate cream
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN PRESCRIPTION DRUG
ITEM CODE (SOURCE)
NDC:70771-1442
ROUTE OF ADMINISTRATION
TOPICAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRENGTH
CLOBETASOL PROPIONATE (UNII: 779619577M) (CLOBETASOL -
UNII:ADN79D536H)
CLOBETASOL
PROPIONATE
0.5 mg
in 1 g
INACTIVE INGREDIENTS
INGREDIENT NAME
STRENGTH
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
CETYL ALCOHOL (UNII: 936JST6JCN)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
ANHYDROUS TRISODIUM CITRATE (UNII: RS7A450LGA)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
POLYSORBATE 60 (UNII: CAL22UVI4M)
LANOLIN OIL (UNII: OVV5IIJ58F)
PETROLATUM (UNII: 4T6H12BN9U)
WATER (UNII: 059QF0KO0R)
Zydus Lifesciences Limited
GLYCOL STEARATE (UNII: 0324G66D0E)
PEG-8 STEARATE (UNII: 2P9L47VI5E)
PACKAGING
#
ITEM CODE
PACKAGE DESCRIPTION
MARKETING START
DATE
MARKETING END
DATE
1
NDC:70771-
1442-1
1 in 1 CARTON
01/09/2019
1
15 g in 1 TUBE; Type 0: Not a Combination
Product
2
NDC:70771-
1442-2
1 in 1 CARTON
01/09/2019
2
30 g in 1 TUBE; Type 0: Not a Combination
Product
3
NDC:70771-
1442-4
1 in 1 CARTON
01/09/2019
3
45 g in 1 TUBE; Type 0: Not a Combination
Product
4
NDC:70771-
1442-3
1 in 1 CARTON
01/09/2019
4
60 g in 1 TUBE; Type 0: Not a Combination
Product
MARKETING INFORMATION
MARKETING
CATEGORY
APPLICATION NUMBER OR MONOGRAPH
CITATION
MARKETING START
DATE
MARKETING END
DATE
ANDA
ANDA211074
01/09/2019
LABELER -
Zydus Lifesciences Limited (918596198)
REGISTRANT -
Zydus Lifesciences Limited (650650802)
ESTABLISHMENT
NAME
ADDRESS
ID/FEI
BUSINESS OPERATIONS
Zydus Lifesciences Limited
650650802
ANALYSIS(70771-1442) , MANUFACTURE(70771-1442)
Revised: 10/2022