HomeNDC LookupIngredientsBetamethasone Valerate › 51672-1269-01
BETAMETHASONE VALERATE 1 mg/g Cream — NDC 51672-1269-01 package photo

BETAMETHASONE VALERATE 1 mg/g Cream

by Sun Pharmaceutical Industries, Inc. · 1 TUBE in 1 CARTON (51672-1269-1) / 15 g in 1 TUBE
NDC 51672-1269-01
🏷️ FDA NDC (as labeled) 51672-1269-1 billing pads the package segment with a zero
This package
Contains15 g in 1 tube Cost per g$0.4124 NADAC Per package$6.19 / 15 g Pack sizes2 compare ↓
Also priced by: Medicaid pays $0.7997/unit · Part D plans $0.6006/unit — full pricing hub ↓
Also comes in: 45 g 51672-1269-06
Rx only Generic 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) 51672-1269-1
Product NDC 51672-1269
11-digit billing NDC 51672126901
NCPDP billing unit GM — per gram (weight)
RxCUI 197407
UNII 9IFA5XM7R2
UPC 0351672126919
Application # ANDA072041
SPL Set ID 3c85be0f-2731-44f1-a18e-d3852d54846f
Established class (EPC) Corticosteroid
Mechanism of action Corticosteroid Hormone Receptor Agonists
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 1988-01-06
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 51672-1269-1 — a 5-4-1 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 package segment → 51672-1269-01. 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

LabelerSun Pharmaceutical Industries, Inc.
Application holderSUN PHARMA CANADA INC
FDA applicationANDA072041 (ANDA)
Labeler code51672
First marketedJan 1988
Product typeHuman Prescription Drug
Portfolio889 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.

💊 What it looks like

Color white
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

🧪 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 867H4YOZ8Z
    A waxy compound made from plant or animal oils mixed with ethylene oxide. It helps oils and water blend together in creams and lotions, and makes the product easier to spread and absorb.
  • UNII 936JST6JCN
    Cetyl alcohol is a waxy, fatty substance derived from plant or animal sources. It acts as an emulsifier and thickener in medicines, helping blend oil and water components and giving products a smooth, creamy texture.
  • 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 U076Q6Q621
    Polyethylene glycol 1000 is a synthetic compound made from ethylene oxide. It serves as a solvent, lubricant, and humectant in medicines, helping dissolve active ingredients and improve how the product flows and feels.
  • UNII 6DC9Q167V3
    Propylene glycol is a clear liquid derived from petroleum or vegetable sources. It acts as a solvent, humectant, and preservative in medicines, helping dissolve active ingredients and maintain product stability.
  • 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 2KR89I4H1Y
    Stearyl alcohol is a waxy, fatty substance derived from natural oils or made synthetically. It acts as an emulsifier and thickener in medicines, helping mix ingredients together and give the product the right texture.
  • 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.

11 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 $0.412 $6.19 / 15 g
Medicaid paysCMS SDUD · 12 mo $0.7997 $12.00 / 15 g
Medicare drug plans payPart D · Q2 2026 $0.6006 $9.01 / 15 g
NADAC price history (per g) — tap or hover for the price & month
Dec 2021 Jul 2022 Dec 2025 Aug 2026 $0.735 $0.380
▼ Down 37% 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/g 00168-0040-15 E. 15 g $0.412 AB Availability likely
Betamethasone Valerate 1.2 mg/g 00713-0326-15 Cosette 1 tube $0.412 AB Availability likely
Betamethasone Valerate 1 mg/gthis 51672-1269-01 Sun 1 tube $0.412 AB Availability likely
Betamethasone Valerate 1 mg/g 00168-0033-15 E. 15 g $0.628 AB Availability likely +52%
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 a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
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

🏛️
1988
On the market since
Jan 1988
📍
2026
Currently FDA-listed
38 years listed
🔓
·
Generic on the market
this product is a generic
This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

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 51672-1269-01, 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
19.5K
Units reimbursed last 4 qtrs
480.5K
Gross reimbursed last 4 qtrs
$384.3K
Avg / prescription
$19.71
Avg / unit
$0.7997
Latest quarter Q4 2025
3.3KRx
Medicaid pays / g
$0.7997
gross reimbursed
vs
NADAC / g
$0.4124
acquisition cost
=
Spread
+$0.3873
+94% 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
23% FFS 77% MCO
Fee-for-service · 4,500 Rx Managed care · 14,999 Rx
State Medicaid map
Alaska: no data reported AK Maine: 2,370 units · 170 per 100k residents ME Washington: 8,130 units · 104 per 100k residents WA Idaho: no data reported ID Montana: 930 units · 82.2 per 100k residents MT North Dakota: no data reported ND Minnesota: 960 units · 16.7 per 100k residents MN Wisconsin: 10,075 units · 170 per 100k residents WI Michigan: 31,475 units · 314 per 100k residents MI New York: 15,390 units · 78.6 per 100k residents NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: 2,670 units · 63.1 per 100k residents OR Nevada: 3,990 units · 125 per 100k residents NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: 810 units · 25.3 per 100k residents IA Illinois: 22,395 units · 178 per 100k residents IL Indiana: 7,215 units · 105 per 100k residents IN Ohio: 35,130 units · 298 per 100k residents OH Pennsylvania: 14,355 units · 111 per 100k residents PA New Jersey: 16,200 units · 174 per 100k residents NJ Massachusetts: 11,372 units · 162 per 100k residents MA California: 39,930 units · 102 per 100k residents CA Utah: 315 units · 9.2 per 100k residents UT Colorado: 4,155 units · 70.7 per 100k residents CO Nebraska: no data reported NE Missouri: 4,245 units · 68.5 per 100k residents MO Kentucky: 3,750 units · 82.9 per 100k residents KY West Virginia: 1,200 units · 67.8 per 100k residents WV Virginia: 10,500 units · 120 per 100k residents VA Maryland: 7,470 units · 121 per 100k residents MD Connecticut: 15,810 units · 437 per 100k residents CT Rhode Island: 2,895 units · 264 per 100k residents RI Arizona: 13,440 units · 181 per 100k residents AZ New Mexico: 2,985 units · 141 per 100k residents NM Kansas: 1,080 units · 36.7 per 100k residents KS Arkansas: 735 units · 24.0 per 100k residents AR Tennessee: 7,331 units · 103 per 100k residents TN North Carolina: 15,634 units · 144 per 100k residents NC South Carolina: 3,165 units · 58.9 per 100k residents SC Delaware: no data reported DE Oklahoma: 1,155 units · 28.5 per 100k residents OK Louisiana: 13,245 units · 290 per 100k residents LA Mississippi: 1,515 units · 51.5 per 100k residents MS Alabama: 1,110 units · 21.7 per 100k residents AL Georgia: 4,965 units · 45.0 per 100k residents GA D.C.: 360 units · 53.0 per 100k residents DC Hawaii: 1,650 units · 115 per 100k residents HI Texas: 14,905 units · 48.9 per 100k residents TX Florida: 18,660 units · 82.5 per 100k residents FL
Units reimbursed · per 100k residents
9.2437
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 Connecticut 437 /100k
2 Michigan 314 /100k
3 Ohio 298 /100k
4 Louisiana 290 /100k
5 Rhode Island 264 /100k
6 Arizona 181 /100k
7 Illinois 178 /100k
8 New Jersey 174 /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.
1 tube this page51672-1269-01 19,499 Rx · $384,263
1 tube51672-1269-06 13,961 Rx · $374,572
Drug total (last 4 qtrs): 33,460 Rx · 1,132,666 units · $758,836 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
51672-1269-01 You're viewing this 1 TUBE in 1 CARTON (51672-1269-1) / 15 g in 1 TUBE $0.4124 / g $6.19 1988-01-06 Active
51672-1269-06 1 TUBE in 1 CARTON (51672-1269-6) / 45 g in 1 TUBE $0.3513 / g $15.81 1988-01-06 Active

Per g, this pack runs about 17% above the cheapest pack (NDC 51672-1269-06, $0.3513 vs $0.4124 NADAC).

In Medicaid, this is the most-dispensed pack of this product — about 58% of fills over the last four reported quarters. See all packs ↓

Pack size FAQ

What quantity is in NDC 51672-1269-01?
NDC 51672-1269-01 is listed by the FDA — 1 tube in 1 carton / 15 g in 1 tube.
What NDC number is used to bill for this package of BETAMETHASONE VALERATE 1 mg/g Cream?
Bill NDC 51672-1269-01 — the 11-digit billing format is 51672126901. 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 33 words

DOSAGE AND ADMINISTRATION Apply a thin film of Betamethasone Valerate Cream USP, 0.1% to the affected skin areas one to three times a day. Dosage once or twice a day is often effective.

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 78 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. To report SUSPECTED ADVERSE REACTIONS, contact Sun Pharmaceutical Industries, Inc., at 1-866-923-4914 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

🤰 Pregnancy 95 words

Pregnancy Teratogenic Effects Pregnancy 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.

🧒 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 33 words

HOW SUPPLIED Betamethasone Valerate Cream USP, 0.1% is supplied in 15 gram (NDC 51672-1269-1) and 45 gram (NDC 51672-1269-6) tubes. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

📦 Storage and Handling 13 words

Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

📋 Description 144 words

DESCRIPTION Betamethasone Valerate Cream USP, 0.1% contains 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: Molecular Formula: C 27 H 37 FO 6 Molecular Weight: 476.59 Each gram of Betamethasone Valerate Cream USP, 0.1% contains 1.2 mg betamethasone valerate (equivalent to 1 mg betamethasone) in a soft, white, hydrophilic cream of ceteareth-15, cetyl alcohol, mineral oil, polyethylene glycol 1000, propylene glycol, purified water, stearyl alcohol, white petrolatum, phosphoric acid and sodium hydroxide (for pH adjustment); chlorocresol is present as a preservative.

Chemical Structure

💬 Information for Patients 121 words

Information For Patients Patients using topical corticosteroids should receive the following information and instructions: This medication is to be used as directed by the physician. It is for external use only. Avoid contact with the eyes.

Patients should be advised not to use this medication for any disorder other than that for which it was prescribed. The treated skin should not be bandaged or otherwise covered or wrapped as to be occlusive unless directed by the physician. Patients should report any signs of local adverse reactions especially under occlusive dressing.

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.