HomeNDC LookupIngredientsBetamethasone Valerate › 00168-0040-46
Betamethasone Valerate 1 mg/g Cream, 45 g — NDC 00168-0040-46 package photo

Betamethasone Valerate 1 mg/g Cream, 45 g

by E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC · 45 g in 1 TUBE (0168-0040-46)
NDC 00168-0040-46
🏷️ FDA NDC (as labeled) 0168-0040-46 billing pads the labeler segment with a zero
This package
Contains45 g Cost per g$0.3513 NADAC Per package$15.81 / 45 g Pack sizes2 compare ↓
Also priced by: Medicaid pays $0.6485/unit · Part D plans $0.6006/unit — full pricing hub ↓
Also comes in: 15 g 00168-0040-15
Rx only Brand On market Non-controlled
🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

🆔 Identity & classification

FDA NDC (as labeled) 0168-0040-46
Product NDC 0168-0040
11-digit billing NDC 00168004046
NCPDP billing unit GM — per gram (weight)
RxCUI 197407, 197408, 197409
UNII 9IFA5XM7R2
UPC 0301680040158
Application # NDA018861
SPL Set ID 0b386ccc-a2d4-4d18-a2d7-e46ff894c674
Established class (EPC) Corticosteroid
Mechanism of action Corticosteroid Hormone Receptor Agonists
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 1983-08-31
Route TOPICAL
Dosage form CREAM
Substance BETAMETHASONE VALERATE
GPI-14 90550020103710
GPI class Betamethasone Valerate
GCN Seq No 007572
GCN 31101
HICL code 002883
Ingredient (HICL) Betamethasone Valerate
HIC1 code Q
Therapeutic class — broad (HIC1) Ear/Eye/Nose/Rectum/Topical/Vagina/Other
HIC2 code Q5
Therapeutic class — intermediate (HIC2) Agents Acting Principally On The Skin
HIC3 code Q5P
Therapeutic class — specific (HIC3) Topical Anti-Inflammatory Steroidal
AHFS code 68:04.00.00
AHFS class Adrenals
FDB label name BETAMETHASONE VA 0.1% CREAM
FDB brand name Betamethasone Valerate
Legend status F — Federal legend — prescription drug or device
TE code (Orange Book) AB · RLD · RS
Why two NDCs? The FDA registers this code as 0168-0040-46 — a 4-4-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the labeler segment → 00168-0040-46. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

🏷️ RxNorm drug class

This medicine belongs to the Corticosteroid class.

Pharmacologic class Corticosteroid
Drug family (ATC) Corticosteroids acting locally, Corticosteroids, Corticosteroids, potent (group III)
How it works Corticosteroid Hormone Receptor Agonists
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

🏭 Manufacturer & labeler

LabelerE. Fougera & Co. a division of Fougera Pharmaceuticals, LLC
Application holderFOUGERA PHARMACEUTICALS LLC
FDA applicationNDA018861 (NDA)
Labeler code00168
First marketedAug 1983
Product typeHuman Prescription Drug
Portfolio33 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

Label name BETAMETHASONE VA 0.1% CREAM Ingredient Betamethasone Valerate
📖 What it is MedlinePlus · NLM

Betamethasone topical is used to treat the itching, redness, dryness, crusting, scaling, inflammation, and discomfort of various skin conditions, including psoriasis (a skin disease in which red, scaly patches form on some areas of the body) and eczema (a skin disease that causes the skin to be dry and itchy and to sometimes develop red, scaly rashes). Betamethasone is in a class of medications called corticosteroids. It works by activating natural substances in the skin to reduce swelling, redness, and itching.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • Betamethasone is a steroid cream (or ointment, gel, spray, or foam) that treats skin conditions where inflammation is the problem — things like eczema, psoriasis, and other conditi...
  • What skin conditions does betamethasone treat?
  • For creams and ointments, apply a thin layer to the affected area once or twice a day — less is more with these products. For the spray (like Sernivo), shake it well first, spray o...
  • That depends on the product. Most creams and ointments should be used for no more than 2 consecutive weeks. The spray forms — including Sernivo — are approved for up to 4 weeks. Yo...
📖 Read our full Betamethasone guide →
8
Nutrient depletion considerations

Betamethasone valerate may be associated with lower levels of 8 nutrients — worth a chat with your pharmacist, not a cause for alarm.

An association is not a deficiency. Educational only — don't start or stop anything without professional guidance.
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

🧪 Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII 2DMT128M1S
    A waxy solid derived from plant or animal sources. It acts as an emulsifier to blend oil and water components, and also thickens the medicine to give it the right texture and consistency.
  • UNII 36W53O7109
    Chlorocresol is a phenolic antimicrobial chemical used as a preservative in liquid medicines and injectable solutions. It prevents bacterial and fungal growth to maintain product safety and shelf-life.
  • UNII T5L8T28FGP
    Mineral oil is a clear, odorless liquid derived from crude oil. It acts as a lubricant and emollient in medications, helping pills slide smoothly during manufacturing and aiding moisture retention in topical products.
  • UNII 4T6H12BN9U
    Petrolatum is a purified mineral oil-based jelly derived from petroleum. In medicines, it acts as an emollient, lubricant, and moisture barrier to soften skin, reduce friction, and help prevent water loss from formulations.
  • UNII E4GA8884NN
    Phosphoric acid is a weak mineral acid used in medicines as a buffer and pH adjuster. It helps stabilize the product and control its acidity level.
  • UNII YRC528SWUY
    A waxy emulsifier made from plant-derived fatty alcohols. It helps blend oil and water-based ingredients together and improves how the medicine spreads and absorbs.
  • UNII 55X04QC32I
    A strong alkaline chemical used to adjust and maintain the pH balance of liquid medicines. It helps keep the medicine stable and ensures it stays effective during storage.
  • UNII 3980JIH2SW
    A salt form of phosphoric acid that acts as a buffer and pH adjuster in medicines. It helps keep the product at the correct acidity level for stability and effectiveness.
  • UNII 059QF0KO0R
    Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.

9 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMedingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

💲 Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer gPer package
Retail pharmacies payNADAC · weekly $0.351 $15.81 / 45 g
Medicaid paysCMS SDUD · 12 mo $0.6485 $29.18 / 45 g
Medicare drug plans payPart D · Q2 2026 $0.6006 $27.03 / 45 g
NADAC price history (per g) — tap or hover for the price & month
Dec 2021 Jul 2022 Dec 2025 Aug 2026 $0.537 $0.348
▼ Down 28% over the last 24 months.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Betamethasone Valerate 1 mg/gthis 00168-0040-46 E. 45 g $0.351 AB Availability likely
Betamethasone Valerate 1.2 mg/g 00713-0326-15 Cosette 1 tube $0.412 AB Availability likely +17%
Betamethasone Valerate 1 mg/g 51672-1269-01 Sun 1 tube $0.412 AB Availability likely +17%
Betamethasone Valerate 1 mg/g 00168-0033-15 E. 15 g $0.628 AB Availability likely +79%
Betamethasone Valerate 1 mg/g 50090-1647-00 A-S 1 tube AB FDA listed
Betamethasone Valerate 1 mg/g 50090-3134-01 A-S 1 tube AB FDA listed
Betamethasone Valerate 1.2 mg/g 50090-3794-01 A-S 1 tube AB FDA listed
Betamethasone Valerate 1.2 mg/g 50090-4696-00 A-S 1 tube AB FDA listed
Betamethasone Valerate 1 mg/g 68071-4278-05 NuCare 15 g AB FDA listed
Betamethasone Valerate 1.2 mg/g 68071-5224-05 NuCare 15 g AB FDA listed
Betamethasone Valerate 1 mg/g 68788-7451-01 Preferred 1 tube AB FDA listed
Betamethasone Valerate 1 mg/g 68788-8450-01 Preferred 15 g AB FDA listed
Betamethasone Valerate 1 mg/g 71205-0040-15 Proficient 15 g AB FDA listed
Betamethasone Valerate 1 mg/g 68788-8496-01 Preferred 15 g AB FDA listed
About this product: this is the brand-name version. FDA-approved generic versions are listed, and recent pricing/market data suggests they may be available.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
1983
On the market since
Aug 1983
📍
2026
Currently FDA-listed
43 years listed
🔓
·
Generic versions listed
see equivalents
Generic appears available

FDA-approved generic versions are listed, and recent pricing/market data suggests they may be available — see Therapeutic equivalents.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

🗺️ Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for 00168-0040-46, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q4 2025 · 4 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
7K
Units reimbursed last 4 qtrs
313.9K
Gross reimbursed last 4 qtrs
$203.6K
Avg / prescription
$29.05
Avg / unit
$0.6485
Latest quarter Q4 2025
1.8KRx
Medicaid pays / g
$0.6485
gross reimbursed
vs
NADAC / g
$0.3513
acquisition cost
=
Spread
+$0.2972
+85% vs cost
What Medicaid paid per g (before rebates; includes the pharmacy’s dispensing fee) compared with NADAC — the average price pharmacies pay to buy the drug. A positive spread means Medicaid reimbursed more than the purchase price, before manufacturer rebates.
Fee-for-service vs managed care
32% FFS 68% MCO
Fee-for-service · 2,256 Rx Managed care · 4,752 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: 3,990 units · 51.1 per 100k residents WA Idaho: no data reported ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: no data reported MN Wisconsin: 5,489 units · 92.9 per 100k residents WI Michigan: 35,908 units · 358 per 100k residents MI New York: 41,261 units · 211 per 100k residents NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: no data reported OR Nevada: 675 units · 21.1 per 100k residents NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: 12,585 units · 100 per 100k residents IL Indiana: 1,215 units · 17.7 per 100k residents IN Ohio: 13,132 units · 111 per 100k residents OH Pennsylvania: 7,890 units · 60.9 per 100k residents PA New Jersey: 375 units · 4.0 per 100k residents NJ Massachusetts: 13,245 units · 189 per 100k residents MA California: 22,800 units · 58.5 per 100k residents CA Utah: no data reported UT Colorado: no data reported CO Nebraska: no data reported NE Missouri: 3,375 units · 54.5 per 100k residents MO Kentucky: 7,065 units · 156 per 100k residents KY West Virginia: 1,845 units · 104 per 100k residents WV Virginia: 8,415 units · 96.5 per 100k residents VA Maryland: 3,570 units · 57.8 per 100k residents MD Connecticut: 7,155 units · 198 per 100k residents CT Rhode Island: 585 units · 53.4 per 100k residents RI Arizona: 1,440 units · 19.4 per 100k residents AZ New Mexico: 1,770 units · 83.7 per 100k residents NM Kansas: no data reported KS Arkansas: 3,120 units · 102 per 100k residents AR Tennessee: 4,665 units · 65.5 per 100k residents TN North Carolina: 9,285 units · 85.7 per 100k residents NC South Carolina: 3,510 units · 65.3 per 100k residents SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: 7,380 units · 161 per 100k residents LA Mississippi: 1,125 units · 38.3 per 100k residents MS Alabama: no data reported AL Georgia: 3,735 units · 33.9 per 100k residents GA D.C.: no data reported DC Hawaii: 1,890 units · 132 per 100k residents HI Texas: 12,535 units · 41.1 per 100k residents TX Florida: 13,590 units · 60.1 per 100k residents FL
Units reimbursed · per 100k residents
4.0358
gray = no data reported
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 Michigan 358 /100k
2 New York 211 /100k
3 Connecticut 198 /100k
4 Massachusetts 189 /100k
5 Louisiana 161 /100k
6 Kentucky 156 /100k
7 Hawaii 132 /100k
8 Ohio 111 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

💊 Medicaid utilization by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.
15 gs00168-0040-15 13,966 Rx · $279,201
45 gs this page00168-0040-46 7,008 Rx · $203,561
Drug total (last 4 qtrs): 20,974 Rx · 652,879 units · $482,763 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

📊 Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Betamethasone Valerate — the program that covers self-administered drugs. 6 manufacturers.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Betamethasone Valerate. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$1.98M
Claims incl. refills
63K
Beneficiaries
49.4K
Spend / beneficiary
$40.10
Spend / claim
$31.44
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

🔬 Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Betamethasone Valerate — the ingredient across all brands.

Top reported reactions

Macular Degeneration644
Pain602
Malaise420
Nausea419
Pyrexia419
Weight Decreased411
Headache407

Reporter sex

4,509 reports
Male · 33%
Female · 67%
Unknown · 0%

Serious outcomes

Life-threatening319
Death235
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 498 0
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDCDescription Per unit Per pack Marketing startStatus
00168-0040-15 15 g in 1 TUBE (0168-0040-15) $0.4124 / g $6.19 1983-08-31 Active
00168-0040-46 You're viewing this 45 g in 1 TUBE (0168-0040-46) $0.3513 / g $15.81 1983-08-31 Active

You're viewing the largest of 2 pack sizes for this product.

This pack has the lowest per-g cost of the 2 priced pack sizes ($0.3513 NADAC).

This pack accounts for about 33% of this product's recent Medicaid fills; most go to the 15 gs pack. See all packs ↓

Pack size FAQ

What quantity is in NDC 00168-0040-46?
NDC 00168-0040-46 contains 45 g — 45 g in 1 tube.
What is the difference between NDC 00168-0040-46 and NDC 00168-0040-15?
Both are Betamethasone Valerate 1 mg/g Cream — the drug itself is identical. NDC 00168-0040-46 is the 45 g package, while NDC 00168-0040-15 is the 15 g package. Per-g NADAC also differs: $0.3513 here vs $0.4124 for the 15 g pack.
What NDC number is used to bill for this package of Betamethasone Valerate 1 mg/g Cream?
Bill NDC 00168-0040-46 — the 11-digit billing format is 00168004046. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage 19 words

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

⏱️ Dosage and Administration 90 words

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. Apply a few drops of Betamethasone Valerate Lotion to the affected area and massage lightly until it disappears.

Apply twice daily, in the morning and at night. Dosage may be increased in stubborn cases. Following improvement, apply once daily.

For the most effective and economical use, apply nozzle very close to affected area and gently squeeze bottle.

Contraindications 21 words

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

🤒 Adverse Reactions 60 words

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.

🧒 Pediatric Use 115 words

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.

🆘 Overdosage 17 words

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

🧬 Clinical Pharmacology 187 words

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.

📦 How Supplied / Storage and Handling 97 words

HOW SUPPLIED: Betamethasone Valerate Betamethasone Valerate Betamethasone Valerate Cream USP, 0.1% Ointment USP, 0.1% Lotion USP, 0.1% is supplied as follows: is supplied as follows: is supplied as follows: 15 g tubes NDC 0168-0040-15 15 g tubes NDC 0168-0033-15 60 mL bottles NDC 0168-0041-60 45 g tubes NDC 0168-0040-46 45 g tubes NDC 0168-0033-46 Shake well before using. Store away from heat and protect from light. Store at room temperature 15° - 30°C (59° - 86°F) [see USP Controlled Room Temperature].

E. FOUGERA & CO. A division of Fougera PHARMACEUTICALS INC.

Melville, NY 11747 46289058A R06/2021 #57

📋 Description 196 words

DESCRIPTION: Betamethasone Valerate Cream, Ointment and Lotion 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: 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, white petrolatum, polyoxyl 20 cetostearyl ether, cetostearyl alcohol, monobasic sodium phosphate and phosphoric acid or sodium hydroxide (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 and mineral oil.

Each gram of the 0.1% Lotion contains 1.2 mg betamethasone valerate (equivalent to 1 mg betamethasone) in a vehicle of isopropyl alcohol and water slightly thickened with carbomer 934P. Sodium hydroxide is used to adjust pH. structural formula

💬 Information for Patients 127 words

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.

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.