Hydrocortisone 25 mg/g Cream, 454 g — NDC 0168-0080-16 (Billing 00168-0080-16)
This is a package of 454 g of Hydrocortisone 25 mg/g Cream from E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC, marketed since Dec 1986 and currently FDA-listed; retail pharmacies pay about $0.1089 per g (NADAC).
NDC database record
One package, one record: these facts belong to NDC 0168-0080-16 alone.
- Record
- FDA NDC Directory package listing · Human prescription drug
- Code segments
- 0168 labeler · 0080 product · 16 package
- Package marketed since
- Dec 16, 1996
- Sample package
- No — commercial package
- Listing certified through
- Dec 31, 2027
- Billing quantity
- 454 g per package
- Barcode (UPC)
- 0301680146300, 0301680080314
- Medicaid fills, this package
- 23,494 prescriptions in the last four reported quarters
- FDA record last changed
- Jul 24, 2026
Past resolved recalls for this product (1)
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification
- GSN (GCN sequence number): 007545
- GCN: 30943
- GPI-14 (Medi-Span): 90550075003725
- HICL (First Databank): 002867
- AHFS class code: 52:08.08.00
- RxCUI (RxNorm): 103401
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 8, 2026
- FDA label on DailyMed · label index refreshed Oct 6, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 8, 2026
RxNorm drug class
This medicine belongs to the Corticosteroid class.
Where does this data come from?
- RxClass (NLM) · catalog refreshed Oct 1, 2026
Clinical
- It depends on the product. Tablets and oral granules are used for adrenal insufficiency, among other conditions. Injections are used for severe allergic states and skin diseases. R...
- Don't stop it suddenly if you take it for adrenal insufficiency. Stopping abruptly can cause adrenal crisis, which can be fatal. Talk to your prescriber before making any changes.
- Common ones are fluid retention, higher blood pressure, changes in blood sugar, mood changes, bigger appetite and weight gain. Call your doctor for signs of infection, vision chang...
- Grapefruit juice and some antifungals and antibiotics can raise hydrocortisone levels. Some seizure medicines and rifampicin can lower them. Tell me about any diabetes medicines, w...
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Hydrocortisone — tap one for details:
Hydrocortisone may be associated with lower levels of 8 nutrients — worth a chat with your pharmacist, not a cause for alarm.
Where does this data come from?
- MedlinePlus (NLM) · refreshed Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 6, 2026
Ask a licensed pharmacist directly — free, answered by our team.
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 system | Per g | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $0.109 | $49.44 / 454 g |
| Medicaid paysCMS SDUD · 12 mo | $0.1118 | $50.76 / 454 g |
| Medicare drug plans payPart D · Q2 2026 | $0.1782 | $80.90 / 454 g |
Where does this data come from?
- CMS NADAC weekly file · file of Oct 7, 2026
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · through Q1 2026
- CMS Part D plan pricing files · refreshed Sep 24, 2026
- VA National Acquisition Center price file
Packaging — all sizes for this product
| Package NDC | Description | Per unit | Per pack | Marketing start | Marketing end | Status |
|---|---|---|---|---|---|---|
| 00168-0080-16 You're viewing this | 454 g in 1 JAR | $0.1089 / g | $49.43 | 1996-12-16 | — | Active |
| 00168-0080-31 0168-0080-31 Main listing | 30 g in 1 TUBE | $0.0919 / g | $2.76 | 1986-12-16 | — | Active |
You're viewing the largest of 2 pack sizes for this product.
Per g, this pack runs about 18% above the cheapest pack (30 g, $0.0919 vs $0.1089 NADAC).
This pack accounts for about 5.3% of this product's recent Medicaid fills; most go to the 30 g pack. See all packs ↓
Pack size FAQ
What quantity is in this package?
How does this package differ from NDC 00168-0080-31?
What NDC number is used to bill for this package of Hydrocortisone 25 mg/g Cream?
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.
Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Hydrocortisone 25 mg/g 00168-0146-16 | E. | 454 g | $0.099 | AT | FDA listed | save 10% |
| Hydrocortisone 25 mg/gthis 00168-0080-16 | E. | 454 g | $0.109 | AT | Availability likely | — |
| Hydrocortisone 25 mg/g 45802-0014-02 | Padagis | 1 tube | $0.122 | AT | Availability likely | +12% |
| Hydrocortisone 25 mg/g 00472-0337-20 | Actavis | 1 tube | $0.125 | — | Discontinued | +15% |
| Hydrocortisone 25 mg/g 45802-0004-02 | Padagis | 1 tube | $0.126 | AT | Availability likely | +15% |
| Hydrocortisone 25 mg/g 62559-0431-30 | ANI | 1 tube | $0.235 | AT | Availability likely | +116% |
| Proctozone-Hc 25 mg/g 64980-0324-30 | Rising | 1 tube | $0.235 | AT | Availability likely | +116% |
| Procto-Med HC 25 mg/g 69315-0312-28 | Leading | 1 tube | $0.235 | AT | Availability likely | +116% |
| Proctosol-HC 25 mg/g 10631-0407-01 | Sun | 1 tube | $0.698 | AT | Availability likely | +541% |
| Alacort 25 mg/g 00316-0128-16 | Crown | 454 g | — | AT | FDA listed | — |
| Hydrocortisone 25 mg/g 00316-0193-16 | Crown | 1 jar | — | AT | FDA listed | — |
| Hydrocortisone 25 mg/g 50090-0244-00 | A-S | 1 tube | — | AT | FDA listed | — |
| Hydrocortisone 25 mg/g 50090-0350-00 | A-S | 1 tube | — | AT | FDA listed | — |
| Hydrocortisone 25 mg/g 50090-2452-00 | A-S | 1 tube | — | AT | FDA listed | — |
| Hydrocortisone 25 mg/g 50090-5999-00 | A-S | 1 tube | — | — | FDA listed | — |
| Hydrocortisone 25 mg/g 51672-3003-00 | Sun | 1 tube | — | AT | FDA listed | — |
| Hydrocortisone 25 mg/g 61919-0364-30 | DIRECT | 30 g | — | AT | FDA listed | — |
| Hydrocortisone 25 mg/g 63187-0480-20 | Proficient | 1 tube | — | — | FDA listed | — |
| Hydrocortisone 25 mg/g 63629-1952-01 | Bryant | 1 tube | — | AT | FDA listed | — |
| Proctozone-Hc 25 mg/g 63629-2396-01 | Bryant | 1 tube | — | AT | FDA listed | — |
| Hydrocortisone 25 mg/g 63629-8666-01 | Bryant | 1 tube | — | AT | FDA listed | — |
| Hydrocortisone 25 mg/g 63629-8667-01 | Bryant | 1 tube | — | AT | FDA listed | — |
| Proctozone-Hc 25 mg/g 63629-8847-01 | Bryant | 1 tube | — | AT | FDA listed | — |
| Anusol HC 25 mg/g 65649-0401-30 | Salix | 1 tube | — | — | FDA listed | — |
| Hydrocortisone 25 mg/g 66267-0967-01 | NuCare | 30 g | — | AT | FDA listed | — |
| Hydrocortisone 25 mg/g 68071-2233-01 | NuCare | 1 tube | — | AT | FDA listed | — |
| Procto-Med HC 25 mg/g 68071-3968-01 | NuCare | 1 tube | — | AT | FDA listed | — |
| Hydrocortisone 25 mg/g 68071-4511-02 | NuCare | 20 g | — | — | FDA listed | — |
| Proctozone-Hc 25 mg/g 68788-7091-03 | Preferred | 1 tube | — | AT | FDA listed | — |
| Hydrocortisone 25 mg/g 68788-8302-03 | Preferred | 1 tube | — | AT | FDA listed | — |
| Hydrocortisone 25 mg/g 68788-8583-02 | Preferred | 1 tube | — | AT | FDA listed | — |
| Hydrocortisone 25 mg/g 68788-9922-03 | Preferred | 1 tube | — | AT | Discontinued | — |
| Hydrocortisone 25 mg/g 70518-3078-00 | REMEDYREPACK | 1 tube | — | AT | FDA listed | — |
| Hydrocortisone 25 mg/g 71335-2954-01 | Bryant | 1 tube | — | AT | FDA listed | — |
| Hydrocortisone 25 mg/g 72162-1382-02 | Bryant | 1 tube | — | AT | FDA listed | — |
| Hydrocortisone 25 mg/g 72162-1764-03 | Bryant | 1 tube | — | AT | FDA listed | — |
| Proctozone-Hc 25 mg/g 72162-1805-02 | Bryant | 1 tube | — | AT | FDA listed | — |
| Proctosol-HC 25 mg/g 72162-2165-02 | Bryant | 1 tube | — | AT | FDA listed | — |
| Hydrocortisone Cream 25 mg/g 72189-0554-28 | Direct_Rx | 20 g | — | AT | FDA listed | — |
| Hydrocortisone Cream 25 mg/g 72189-0625-30 | Direct_Rx | 1 g | — | AT | FDA listed | — |
| Hydrocortisone 25 mg/g 82804-0135-28 | Proficient | 1 tube | — | AT | FDA listed | — |
| Hydrocortisone 25 mg/g 85766-0081-30 | Sportpharm | 30 g | — | AT | FDA listed | — |
| Hydrocortisone 25 mg/g 85766-0085-30 | Sportpharm | 1 tube | — | AT | FDA listed | — |
| Hydrocortisone 25 mg/g 63629-8817-01 | Bryant | 29 g | — | AT | FDA listed | — |
| Hydrocortisone 25 mg/g 82804-0084-20 | Proficient | 1 tube | — | AT | FDA listed | — |
| Hydrocortisone 25 mg/g 50090-0527-00 | A-S | 1 tube | — | AT | FDA listed | — |
| Hydrocortisone 25 mg/g 63629-2527-01 | Bryant | 454 g | — | AT | FDA listed | — |
| Hydrocortisone 25 mg/g 72162-1383-04 | Bryant | 1 tube | — | AT | FDA listed | — |
| Hydrocortisone 25 mg/g 63629-9057-01 | Bryant | 1 tube | — | AT | FDA listed | — |
| Hydrocortisone 25 mg/g 63629-2528-01 | Bryant | 1 tube | — | AT | FDA listed | — |
| Hydrocortisone 25 mg/g 21922-0065-05 | Encube | 1 tube | — | AT | FDA listed | — |
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 8, 2026
- FDA Orange Book · refreshed Oct 3, 2026
- CMS NADAC weekly file · file of Oct 7, 2026
Availability & generic status
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?
- FDA Orange Book · refreshed Oct 3, 2026
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.
🧪 Avoiding an ingredient? See Hydrocortisone inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
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UNII LKG8494WBH
Benzyl alcohol is a clear liquid used as a preservative and solvent in medicines. It helps prevent bacterial and fungal growth and dissolves other ingredients to create uniform liquid formulations.
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UNII PDC6A3C0OX
Glycerin is a clear, thick liquid derived from plant oils or fats. It acts as a humectant to retain moisture, a sweetener, and a solvent in medications.
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UNII 230OU9XXE4
A waxy substance made from glycerin and stearic acid that acts as an emulsifier to blend oily and watery ingredients together. It also helps thicken and stabilize the medicine's texture.
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UNII 8CRQ2TH63M
Isopropyl palmitate is an oily liquid derived from palm oil. It acts as an emollient and lubricant in medicines, helping soften the skin or improve how the product spreads and flows.
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UNII 33X04XA5AT
Lactic acid is a naturally occurring organic acid derived from milk or plant sources. It lowers and maintains pH in formulations, helps preserve the product, and can enhance ingredient stability and absorption.
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UNII I9O0E3H2ZE
Paraffin is a waxy, petroleum-derived substance used as a coating, lubricant, and hardening agent in tablets and capsules. It helps protect the medicine from moisture and gives pills a smooth finish.
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UNII 13A4J4NH9I
A synthetic emulsifier derived from stearic acid and polyethylene glycol. It helps mix oil and water-based ingredients together in liquid medicines and creams to create a smooth, uniform product.
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UNII 1VPU26JZZ4
Potassium sorbate is a salt derived from sorbic acid, a naturally occurring preservative. It prevents growth of mold, yeast, and some bacteria, extending the medicine's shelf life.
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UNII NVZ4I0H58X
A waxy substance made from sorbitol and stearic acid. It acts as an emulsifier and stabilizer, helping keep oil and water mixed together and preventing separation in the medicine.
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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.
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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?
ingredient 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.- FDA label on DailyMed · label index refreshed Oct 6, 2026
- FDA openFDA NDC Directory · synced Oct 8, 2026
Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
Why might an inactive ingredient be missing?
Can inactive ingredients matter?
Manufacturer & labeler
More NDCs from E. Fougera & Co. a division of Fougera Pharmaceu... labeler code 00168
- Betamethasone Valerate 1 mg/mL Lotion NDC 0168-0041-60
- Betamethasone Dipropionate .5 mg/g Cream NDC 0168-0055-15
- Betamethasone Dipropionate .5 mg/g Ointment NDC 0168-0056-15
- Betamethasone Dipropionate .5 mg/mL Lotion NDC 0168-0057-60
- Fluocinolone Acetonide .1 mg/mL Solution NDC 0168-0059-60
- Fluocinolone Acetonide .25 mg/g Ointment NDC 0168-0064-15
- ketoconazole 20 mg/g Cream NDC 0168-0099-15
- Swim-EAR 950 mg/mL Solution NDC 0168-0126-91
- Clotrimazole 10 mg/g Cream NDC 0168-0133-15
- fluocinonide .5 mg/mL Solution NDC 0168-0134-60
- Hydrocortisone 25 mg/g Ointment NDC 0168-0146-16
- Clobetasol Propionate .5 mg/g Ointment NDC 0168-0162-15
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 8, 2026
- Drugs@FDA
Full prescribing information FDA SPL
🎯 Indications and Usage ▾
INDICATIONS AND USAGE Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.
⏱️ Dosage and Administration ▾
DOSAGE AND ADMINISTRATION Apply to the affected area as a thin film 2 to 4 times daily depending on the severity of the condition. Occlusive dressings may be used for the management of psoriasis or recalcitrant conditions. If an infection develops, the use of occlusive dressings should be discontinued and appropriate antimicrobial therapy instituted.
⛔ Contraindications ▾
CONTRAINDICATIONS Topical corticosteroids are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.
🤒 Adverse Reactions ▾
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.
🤰 Pregnancy ▾
Pregnancy: Teratogenic Effects –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 ▾
Pediatric Use: Pediatric patients may demonstrate greater susceptibility to topical corticosteroid-induced hypothalamic-pituitary-adrenal (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 pediatric patients receiving topical corticosteroids. Manifestations of adrenal suppression in pediatric patients 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 pediatric patients.
🆘 Overdosage ▾
OVERDOSAGE Topically applied corticosteroids can be absorbed in sufficient amounts to produce systemic effects (see PRECAUTION S ).
🧬 Clinical Pharmacology ▾
CLINICAL PHARMACOLOGY Topical corticosteroids share anti-inflammatory, anti-pruritic 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 (see DOSAGE AND ADMINISTRATION ).
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 ▾
HOW SUPPLIED Hydrocortisone Cream USP, 2.5% Hydrocortisone Ointment USP, 2.5% a white cream is available as follows: a white ointment is available as follows: NDC 0168-0080-31 30 g Tubes NDC 0168-0146-30 28.35 g (1 oz) Tubes NDC 0168-0080-16 453.6 g (1 Lb) Jars NDC 0168-0146-16 453.6 g (1 Lb) Jars Store at controlled room temperature 15° to 30°C (59° to 86°F). E. FOUGERA & CO. A division of Fougera PHARMACEUTICALS INC. Melville, New York 11747 Rev. 07/2024
📋 Description ▾
DESCRIPTION The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and anti-pruritic agents. Hydrocortisone Cream USP, 2.5% and Hydrocortisone Ointment USP, 2.5% contains hydrocortisone, USP. Hydrocortisone is a white to practically white crystalline powder.
Chemically, hydrocortisone is pregn-4-ene-3,20-dione, 11,17, 21-trihydroxy-, (11β)-. The structural formula of hydrocortisone is: Molecular Formula: C 21 H 30 O 5 Molecular Weight: 362.47 Each gram of the 2.5% Cream contains 25 mg of hydrocortisone, USP in a base of glyceryl monostearate, polyoxyl 40 stearate, glycerin, paraffin, stearyl alcohol, isopropyl palmitate, sorbitan monostearate, benzyl alcohol, potassium sorbate, lactic acid and purified water. Each gram of the 2.5% Ointment contains 25 mg of hydrocortisone, USP in a base of white petrolatum and mineral oil. chemical-structure
💬 Information for Patients ▾
Information for the Patient: 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 for which it was prescribed.
3. The treated skin area should not be bandaged or otherwise covered or wrapped so 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.
⚠️ Precautions ▾
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 or under an occlusive dressing 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 to substitute 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.
Children 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 the Patient: 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 for which it was prescribed. 3. The treated skin area should not be bandaged or otherwise covered or wrapped so 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 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 Effects –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 suscep… [Excerpted — this section continues on DailyMed.]
🍼 Nursing Mothers ▾
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.
📄 Carcinogenesis, Mutagenesis, Impairment of Fertility ▾
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.
📄 Package Label / Principal Display Panel ▾
PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 1 OZ CONTAINER NDC 0168-0146-30 Hydrocortisone Ointment USP, 2.5% For External Use Only Not for Ophthalmic Use FOUGERA ® Rx only Each gram for topical administration contains: 25 mg of hydrocortisone, USP in a base of white petrolatum and mineral oil. Net Wt. 28.35 g (1 Oz) tube-ont
PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 1 OZ CARTON NDC 0168-0146-30 Rx only Hydrocortisone Ointment USP, 2.5% For External Use Only Not for Ophthalmic Use FOUGERA ® Net Wt. 28.35 g (1 Oz) carton-ont
PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 30 GM CONTAINER NDC 0168-0080-31 Hydrocortisone Cream USP, 2.5% For External Use Only Not for Ophthalmic Use FOUGERA ® Rx only Each gram for topical administration contains: 25 mg of hydrocortisone, USP in a base of glyceryl monostearate, polyoxyl 40 stearate, glycerin, paraffin, stearyl alcohol, isopropyl palmitate, sorbitan monostearate, benzyl alcohol, potassium sorbate, lactic acid and purified water. Net Wt. 30 grams tube-crm
PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 30 GM CARTON NDC 0168-0080-31 Rx only Hydrocortisone Cream USP, 2.5% For External Use Only Not for Ophthalmic Use FOUGERA ® Net Wt. 30 grams carton-crm