BETAMETHASONE VALERATE- betamethasone valerate cream 
BETAMETHASONE VALERATE- betamethasone valerate ointment 
Cosette Pharmaceuticals, Inc.

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BETAMETHASONE VALERATE CREAM USP, 0.1%
BETAMETHASONE VALERATE OINTMENT USP, 0.1%
(Potency expressed as betamethasone)

Rx only

FOR DERMATOLOGIC USE ONLY.
NOT FOR OPHTHALMIC USE.

DESCRIPTION

Betamethasone Valerate Cream and Ointment contain betamethasone valerate USP, a synthetic adrenocorticosteroid for dermatologic use. Betamethasone, an analog of prednisolone, has a high degree of glucocorticoid activity and a slight degree of mineralocorticoid activity.

Betamethasone valerate is a white to practically white odorless crystalline powder practically insoluble in water, freely soluble in acetone and chloroform, soluble in alcohol, and slightly soluble in benzene and ether. Chemically, it is 9-fluoro-11β,17,21-trihydroxy-16β-methylpregna-1,4-diene-3,20-dione 17-valerate. The structural formula is: 

structural formula

Each gram of the 0.1% Cream contains 1.2 mg betamethasone valerate (equivalent to 1 mg betamethasone) in a soft, white, hydrophilic cream of purified water, mineral oil, sodium phosphate monobasic (monohydrate), white petrolatum, polyethylene glycol 1000, ceteareth-15, stearyl alcohol, cetyl alcohol, propylene glycol, phosphoric acid (to adjust pH, if required); chlorocresol is present as a preservative.

Each gram of the 0.1% Ointment contains 1.2 mg betamethasone valerate (equivalent to 1 mg betamethasone) in an ointment base of white petrolatum, mineral oil, and hydrogenated lanolin.

CLINICAL PHARMACOLOGY

Topical corticosteroids share anti-inflammatory, antipruritic and vasoconstrictive actions.

The mechanism of anti-inflammatory activity of the topical corticosteroids is unclear. Various laboratory methods, including vasoconstrictor assays, are used to compare and predict potencies and/or clinical efficacies of the topical corticosteroids. There is some evidence to suggest that a recognizable correlation exists between vasoconstrictor potency and therapeutic efficacy in man.

Pharmacokinetics

The extent of percutaneous absorption of topical corticosteroids is determined by many factors including the vehicle, the integrity of the epidermal barrier, and the use of occlusive dressings.

Topical corticosteroids can be absorbed from normal intact skin. Inflammation and/or other disease processes in the skin increase percutaneous absorption. Occlusive dressings substantially increase the percutaneous absorption of topical corticosteroids. Thus, occlusive dressings may be a valuable therapeutic adjunct for treatment of resistant dermatoses.

Once absorbed through the skin, topical corticosteroids are handled through pharmacokinetic pathways similar to systemically administered corticosteroids. Corticosteroids are bound to plasma proteins in varying degrees. Corticosteroids are metabolized primarily in the liver and are then excreted by the kidneys. Some of the topical corticosteroids and their metabolites are also excreted into the bile.

INDICATIONS AND USAGE

Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.

CONTRAINDICATIONS

Topical corticosteroids are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.

PRECAUTIONS

General

Systemic absorption of topical corticosteroids has produced reversible hypothalamic-pituitary-adrenal (HPA) axis suppression, manifestations of Cushing's syndrome, hyperglycemia, and glucosuria in some patients.

Conditions which augment systemic absorption include the application of the more potent steroids, use over large surface areas, prolonged use, and the addition of occlusive dressings.

Therefore, patients receiving a large dose of a potent topical steroid applied to a large surface area should be evaluated periodically for evidence of HPA axis suppression by using the urinary free cortisol and ACTH stimulation tests. If HPA axis suppression is noted, an attempt should be made to withdraw the drug, to reduce the frequency of application, or substitute to a less potent steroid.

Recovery of HPA axis function is generally prompt and complete upon discontinuation of the drug. Infrequently, signs and symptoms of steroid withdrawal may occur, requiring supplemental systemic corticosteroids.

Pediatric patients may absorb proportionally larger amounts of topical corticosteroids and thus be more susceptible to systemic toxicity (See PRECAUTIONS—Pediatric Use).

If irritation develops, topical corticosteroids should be discontinued and appropriate therapy instituted.

In the presence of dermatological infections, the use of an appropriate antifungal or antibacterial agent should be instituted. If a favorable response does not occur promptly, the corticosteroid should be discontinued until the infection has been adequately controlled.

Information for Patients

Patients using topical corticosteroids should receive the following information and instructions:

1. This medication is to be used as directed by the physician.. It is for external use only. Avoid contact with the eyes.
2. Patients should be advised not to use this medication for any disorder other than that for which it was prescribed.
3. The treated skin area should not be bandaged or otherwise covered or wrapped as to be occlusive unless directed by the physician.
4. Patients should report any signs of local adverse reactions especially under occlusive dressing.
5. Parents of pediatric patients should be advised not to use tight-fitting diapers or plastic pants on a child being treated in the diaper area, as these garments may constitute occlusive dressings.

Laboratory tests

The following tests may be helpful in evaluating the HPA axis suppression:
    Urinary free cortisol test
    ACTH stimulation test

Carcinogenesis, Mutagenesis and Impairment of Fertility

Long-term animal studies have not been performed to evaluate the carcinogenic potential or the effect on fertility of topical corticosteroids.

Studies to determine mutagenicity with prednisolone and hydrocortisone have revealed negative results.

Pregnancy

Teratogenic EffectsPregnancy Category C
Corticosteroids are generally teratogenic in laboratory animals when administered systemically at relatively low dosage levels. The more potent corticosteroids have been shown to be teratogenic after dermal application in laboratory animals. There are no adequate and well-controlled studies in pregnant women on teratogenic effects from topically applied corticosteroids. Therefore, topical corticosteroids should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Drugs of this class should not be used extensively on pregnant patients, in large amounts, or for prolonged periods of time.

Nursing Mothers

It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in breast milk. Systemically administered corticosteroids are secreted into breast milk in quantities not likely to have a deleterious effect on the infant. Nevertheless, caution should be exercised when topical corticosteroids are administered to a nursing woman.

Pediatric Use

Pediatric patients may demonstrate greater susceptibility to topical corticosteroid-induced HPA axis suppression and Cushing's syndrome than mature patients because of a larger skin surface area to body weight ratio.

Hypothalamic-pituitary-adrenal (HPA) axis suppression, Cushing's syndrome, and intracranial hypertension have been reported in children receiving topical corticosteroids. Manifestations of adrenal suppression in children include linear growth retardation, delayed weight gain, low plasma cortisol levels, and absence of response to ACTH stimulation. Manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema.

Administration of topical corticosteroids to pediatric patients should be limited to the least amount compatible with an effective therapeutic regimen. Chronic corticosteroid therapy may interfere with the growth and development of children.

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, maceration of the skin, secondary infection, skin atrophy, striae and miliaria.

To report SUSPECTED ADVERSE REACTIONS, contact Cosette Pharmaceuticals, Inc. at 1-800-922-1038 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

OVERDOSAGE

Topically applied corticosteroids can be absorbed in sufficient amounts to produce systemic effects (See PRECAUTIONS).

DOSAGE AND ADMINISTRATION

Apply a thin film of Betamethasone Valerate Cream or Ointment to the affected skin areas one to three times a day. Dosage once or twice a day is often effective.

HOW SUPPLIED

Betamethasone Valerate Cream USP, 0.1% is supplied as follows:
15 g tubes NDC 0713-0326-15
45 g tubes NDC 0713-0326-37

Betamethasone Valerate Ointment USP, 0.1% is supplied as follows:
15 g tubes NDC 0713-0327-15
45 g tubes NDC 0713-0327-37

Store at room temperature 15°-30°C (59°-86°F) [see USP Controlled Room Temperature].

Manufactured by:

Cosette Pharmaceuticals, Inc.

111 Coolidge Street

South Plainfield, NJ 07080

8-BETVCP1

Iss. 08/2019

NDC 0713-0326-15

Betamethasone Valerate Cream, USP 0.1%

15 g

Rx only

FOR DERMATOLOGIC USE ONLY. NOT FOR OPHTHALMIC USE.

Cosette Pharmaceuticals, Inc.

Graphical user interface, text, application

Description automatically generated
Text

Description automatically generated

NDC 0713-0326-37

Betamethasone Valerate Cream, USP 0.1%

45 g

Rx only

FOR DERMATOLOGIC USE ONLY. NOT FOR OPHTHALMIC USE.

Cosette Pharmaceuticals, Inc.

Graphical user interface, text, application

Description automatically generated
Text

Description automatically generated

NDC 0713-0327-15

Betamethasone Valerate Ointment, USP 0.1%

15 g

Rx only

FOR DERMATOLOGIC USE ONLY. NOT FOR OPHTHALMIC USE.

Cosette Pharmaceuticals, Inc.

Text

Description automatically generated
Graphical user interface, text

Description automatically generated

NDC 0713-0327-37

Betamethasone Valerate Ointment, USP 0.1%

45 g

Rx only

FOR DERMATOLOGIC USE ONLY. NOT FOR OPHTHALMIC USE.

Cosette Pharmaceuticals, Inc.

Text

Description automatically generated
Text

Description automatically generated
BETAMETHASONE VALERATE 
betamethasone valerate cream
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0713-0326
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BETAMETHASONE VALERATE (UNII: 9IFA5XM7R2) (BETAMETHASONE - UNII:9842X06Q6M) BETAMETHASONE VALERATE1.2 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
MINERAL OIL (UNII: T5L8T28FGP)  
SODIUM PHOSPHATE, MONOBASIC (UNII: 3980JIH2SW)  
PETROLATUM (UNII: 4T6H12BN9U)  
POLYETHYLENE GLYCOL 1000 (UNII: U076Q6Q621)  
CETEARETH-15 (UNII: 867H4YOZ8Z)  
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
PHOSPHORIC ACID (UNII: E4GA8884NN)  
CHLOROCRESOL (UNII: 36W53O7109)  
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0713-0326-151 in 1 CARTON08/27/2015
115 g in 1 TUBE; Type 0: Not a Combination Product
2NDC:0713-0326-371 in 1 CARTON08/27/2015
245 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA01864203/24/1983
BETAMETHASONE VALERATE 
betamethasone valerate ointment
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0713-0327
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BETAMETHASONE VALERATE (UNII: 9IFA5XM7R2) (BETAMETHASONE - UNII:9842X06Q6M) BETAMETHASONE VALERATE1.2 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
PETROLATUM (UNII: 4T6H12BN9U)  
MINERAL OIL (UNII: T5L8T28FGP)  
LANOLIN ALCOHOLS (UNII: 884C3FA9HE)  
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0713-0327-151 in 1 CARTON08/27/2015
115 g in 1 TUBE; Type 0: Not a Combination Product
2NDC:0713-0327-371 in 1 CARTON08/27/2015
245 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07006912/19/1985
Labeler - Cosette Pharmaceuticals, Inc. (116918230)
Registrant - Cosette Pharmaceuticals, Inc. (116918230)
Establishment
NameAddressID/FEIBusiness Operations
Cosette Pharmaceuticals, Inc.116918230analysis(0713-0326, 0713-0327) , label(0713-0326, 0713-0327) , manufacture(0713-0326, 0713-0327) , pack(0713-0326, 0713-0327)

Revised: 12/2020
Document Id: acdbda4b-da14-4049-b628-09fd208eee8e
Set id: 784476d2-5e5c-fdba-a677-8973a777b5ef
Version: 8
Effective Time: 20201216
 
Cosette Pharmaceuticals, Inc.