Hydrocortisone 10 mg/g Cream, 1 tube — NDC 62559-430-01 (Billing 62559-0430-01)
This is a package of 1 tube of Hydrocortisone 10 mg/g Cream from ANI Pharmaceuticals, Inc., marketed since Apr 2016 and currently FDA-listed; retail pharmacies pay about $0.6001 per g (NADAC). It is this product's only package size.
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): 006859
- GCN: 28851
- GPI-14 (Medi-Span): 89100010003705
- HICL (First Databank): 002867
- AHFS class code: 52:08.08.00
- RxCUI (RxNorm): 106258
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 1, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 1, 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
Hydrocortisone topical is used to treat redness, swelling, itching, and discomfort of various skin conditions. Hydrocortisone 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 ↗- 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 1, 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 | $0.600 | $17.04 / 28.4 g |
| Medicaid paysCMS SDUD · 12 mo | $0.9171 | $26.05 / 28.4 g |
| Medicare drug plans payPart D · Q2 2026 | $0.4138 | $11.75 / 28.4 g |
Where does this data come from?
- CMS NADAC weekly file · file of Sep 30, 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 | Marketing start | Marketing end | Status |
|---|---|---|---|---|
| 62559-0430-01 You're viewing this Main listing | 1 TUBE in 1 CARTON / 28.4 g in 1 TUBE | 2016-04-01 | — | Active |
Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Leader Hydrocortisone With Aloe .01 g/g 70000-0543-01 | LEADER | 1 tube | $0.056 | — | FDA listed | save 91% |
| Hydrocortisone Cream with Aloe 1 g/100g 00536-1407-95 | Rugby | 1 tube | $0.059 | — | Availability likely | save 90% |
| Hydrocortisone Cream with Aloe 1 g/100g 70000-0662-01 | Cardinal | 1 tube | $0.059 | — | Availability likely | save 90% |
| Good Neighbor Pharmacy Hydrocortisone with Aloe 1 g/100g 24385-0274-03 | AmerisourceBergen | 1 tube | $0.059 | — | Availability likely | save 90% |
| good sense anti itch 1 g/100g 00113-0541-64 | L. | 1 tube | $0.061 | — | Availability likely | save 90% |
| Good Neighbor Pharmacy Hydrocortisone Plus 12 Moisturizers 1 g/100g 24385-0021-03 | AmerisourceBergen | 1 tube | $0.061 | — | Availability likely | save 90% |
| hydrocortisone 1 g/100g 45802-0438-03 | Padagis | 1 tube | $0.061 | — | Availability likely | save 90% |
| Hydrocortisone Plus 12 Moisturizers 1 g/100g 51672-2063-02 | Sun | 1 tube | $0.061 | — | Availability likely | save 90% |
| Hydrocortisone Acetate Antipruritic (Anti-Itch) 1 g/100g 51672-2069-02 | Sun | 1 tube | $0.061 | — | Availability likely | save 90% |
| Hydrocortisone 1 g/100g 68001-0476-46 | BluePoint | 1 tube | $0.061 | — | Availability likely | save 90% |
| Hydrocortisone 1 g/100g 70000-0485-01 | Cardinal | 1 tube | $0.061 | — | Availability likely | save 90% |
| Hydrocortisone 1% 1 g/100g 83324-0047-01 | Chain | 1 tube | $0.062 | — | Availability likely | save 90% |
| Itch Relief 1 g/100g 70677-1215-01 | STRATEGIC | 1 tube | $0.072 | — | Availability likely | save 88% |
| Hydrocortisone with Aloe 1 g/100g 70677-1216-01 | STRATEGIC | 1 tube | $0.072 | — | Availability likely | save 88% |
| Sunmark Hydrocortisone with Aloe Maximum Strength 1 g/100g 49348-0521-72 | Strategic | 1 tube | $0.093 | — | Discontinued | save 85% |
| hydrocortisone 10 mg/g 00168-0015-16 | E. | 453.6 g | $0.109 | AT | Availability likely | save 82% |
| Hydrocortisone 10 mg/g 00472-0321-26 | Actavis | 1 tube | $0.112 | AT | Availability likely | save 81% |
| Hydrocortisone with Aloe 1 g/100g 51672-2013-01 | Sun | 1 tube | $0.135 | — | Availability likely | save 78% |
| Hydrocortisone with Aloe 1 g/100g 51672-5330-01 | Sun | 1 tube | $0.135 | — | Availability likely | save 78% |
| Hydrocortisone 10 mg/g 00168-0020-16 | E. | 453.6 g | $0.138 | AT | Availability likely | save 77% |
| Hydrocortisone 10 mg/gthis 62559-0430-01 | ANI | 1 tube | $0.600 | AT | Availability likely | — |
| Alacort 10 mg/g 00316-0126-01 | Crown | 1 tube | — | AT | FDA listed | — |
| Hydrocortisone 10 mg/g 00316-0186-01 | Crown | 1 tube | — | AT | FDA listed | — |
| Hydrocortisone Cream Intensive Healing 1 g/100g 00363-0237-03 | Walgreens | 1 tube | — | — | FDA listed | — |
| Maximum Strength Hydrocortisone Cream with Aloe 1 g/100g 00363-0620-03 | Walgreens | 1 tube | — | — | FDA listed | — |
| Maximum Strength Hydrocortisone Cream 1 g/100g 00363-0638-04 | Walgreens | 1 tube | — | — | FDA listed | — |
| Hydrocortisone 1 g/100g 00363-0972-02 | Walgreen | 1 tube | — | — | FDA listed | — |
| Hydrocortisone 1 g/100g 00363-1973-16 | Walgreen | 1 tube | — | — | FDA listed | — |
| Hydrocortisone 10 mg/g 00363-9981-02 | Walgreens | 1 tube | — | — | FDA listed | — |
| Hydrocortisone 1 g/100g 00404-0166-50 | Henry | 1 tube | — | — | FDA listed | — |
| Hydrocortisone 10 mg/g 00924-1133-00 | Acme | 9 g | — | — | FDA listed | — |
| First Aid Only Hydrocortisone 1% Anti-Itch 10 mg/g 00924-5633-00 | Acme | 9 g | — | — | FDA listed | — |
| Anti itch 1 g/100g 11383-0292-01 | Weeks | 28 g | — | — | FDA listed | — |
| Anti-itch Paraben Free 1 g/100g 11383-0313-01 | Weeks | 1 tube | — | — | FDA listed | — |
| Dr. Sheffield Hydrocortisone Anti itch 10 mg/g 11527-0052-51 | Sheffield | 1 tube | — | — | FDA listed | — |
| Hydrocortisone Intensive Healing Formula 1 g/100g 11673-0398-02 | TARGET | 1 tube | — | — | FDA listed | — |
| Hydrocortisone Plus 12 Moisturizers 1 g/100g 11673-0399-02 | TARGET | 1 tube | — | — | FDA listed | — |
| up and up hydrocortisone anti itch 1 g/100g 11673-0842-00 | Target | 2 tubes | — | — | Discontinued | — |
| Maximum Strength Hydrocortisone Anti-itch 10 mg/g 11673-0890-56 | Target | 2 tubes | — | — | FDA listed | — |
| Hydrocortisone 1 g/100g 11822-2069-02 | Rite | 1 tube | — | — | FDA listed | — |
| Hydrocortisone Plus 12 Moisturizers 1 g/100g 11822-2090-02 | RITE | 1 tube | — | — | FDA listed | — |
| Rite Aid anti-itch 1 g/100g 11822-2099-03 | Rite | 1 tube | — | — | FDA listed | — |
| Rite Aid Anti-itch 1 g/100g 11822-3130-01 | Rite | 1 tube | — | — | FDA listed | — |
| Signature Care Anti Itch 1 g/100g 21130-0278-64 | Safeway | 1 tube | — | — | FDA listed | — |
| Signature Care Hydrocortisone 1 g/100g 21130-0369-64 | Safeway | 1 tube | — | — | FDA listed | — |
| Signature Care Hydrocortisone 1 g/100g 21130-0395-16 | Safeway | 1 tube | — | — | FDA listed | — |
| Anti Itch 1 g/100g 21130-0433-64 | Safeway | 1 tube | — | — | FDA listed | — |
| hydrocortisone 1 g/100g 21130-0449-16 | Safeway | 1 tube | — | — | FDA listed | — |
| Signature Care Hydrocortisone 1 g/100g 21130-0993-64 | Safeway | 1 tube | — | — | FDA listed | — |
| Hydrocortisone 1 g/100g 21922-0096-04 | Encube | 1 tube | — | — | FDA listed | — |
| Hydrocortisone with aloe 1 g/100g 21922-0097-04 | Encube | 1 tube | — | — | FDA listed | — |
| Hydrocortisone 1% Anti-Itch Cream 1 g/100g 24286-1578-01 | DLC | 1 tube | — | — | FDA listed | — |
| ProCure Hydrocortisone Cream Plus 10 mg/g 29784-0142-28 | Rooftop | 1 tube | — | — | FDA listed | — |
| hydrocortisone 1 1 g/100g 30142-0369-64 | Kroger | 1 tube | — | — | FDA listed | — |
| Hydrocortisone 1 g/100g 30142-0411-16 | Kroger | 1 tube | — | — | FDA listed | — |
| hydrocortisone 1 g/100g 30142-0973-64 | Kroger | 1 tube | — | — | FDA listed | — |
| TopCare Hydrocortisone Plus 12 Moisturizers 1 g/100g 36800-0051-06 | Topco | 1 tube | — | — | FDA listed | — |
| TopCare Hydrocortisone Intensive Healing Formula 1 g/100g 36800-0099-02 | Topco | 1 tube | — | — | FDA listed | — |
| topcare hydrocortisone 1 g/100g 36800-0524-26 | Topco | 2 tubes | — | — | FDA listed | — |
| topcare hydrocortisone 1 g/100g 36800-0939-64 | Topco | 1 tube | — | — | FDA listed | — |
| Topcare Hydrocortisone 1 g/100g 36800-0981-64 | Topco | 1 tube | — | — | FDA listed | — |
| Shopko Hydrocortisone Maximum Strength 1 g/100g 37012-0059-02 | Shopko | 1 tube | — | — | FDA listed | — |
| Hydrocortisone 1 g/100g 37808-0319-64 | H | 1 tube | — | — | FDA listed | — |
| hydrocortisone anti itch 1 g/100g 37808-0369-64 | H | 1 tube | — | — | FDA listed | — |
| hydrocortisone 1 g/100g 37808-0973-64 | H | 1 tube | — | — | FDA listed | — |
| equaline anti itch 1 g/100g 41163-0319-16 | United | 1 tube | — | — | FDA listed | — |
| equaline anti itch maximum strength 1 g/100g 41163-0369-64 | United | 1 tube | — | — | FDA listed | — |
| equaline anti itch maximum strength 1 g/100g 41163-0973-64 | United | 1 tube | — | — | FDA listed | — |
| Cortizone-10 Soothing Aloe Creme 1 g/100g 41167-0021-00 | Chattem, | 1 tube | — | — | FDA listed | — |
| Cortisone 10 Intensive Moisture Creme 1 g/100g 41167-0022-00 | Chattem, | 1 tube | — | — | FDA listed | — |
| Cortizone 10 Intensive Healing Itch Relief Cream 1 g/100g 41167-0023-00 | Chattem, | 1 tube | — | — | FDA listed | — |
| Cortizone 10 Soothing Aloe Itch Relief 1 g/100g 41167-0024-00 | Chattem, | 1 tube | — | — | FDA listed | — |
| Cortizone 10 Ultra Soothing Creme 1 g/100g 41167-0027-00 | Chattem, | 1 tube | — | — | FDA listed | — |
| Cortisone 10 Sensitive Skin Creme 1 g/100g 41167-0028-00 | Chattem, | 1 tube | — | — | FDA listed | — |
| Cortizone 10 Ultra Soothing Itch Relief 1 g/100g 41167-0029-00 | Chattem, | 1 tube | — | — | FDA listed | — |
| Cortizone 10 Intensive Healing 10 mg/g 41167-0035-00 | Chattem, | 1 tube | — | — | FDA listed | — |
| Cortizone 10 10 mg/g 41167-0039-00 | Chattem, | 1 tube | — | — | Discontinued | — |
| Cortisone 10 Overnight Creme 1 g/100g 41167-0109-02 | Chattem, | 1 tube | — | — | FDA listed | — |
| Cortizone 10 Feminine Itch Relief 1 g/100g 41167-0330-03 | Chattem, | 1 tube | — | — | FDA listed | — |
| Cortizone 10 Itch Relief Massaging Rollerball 1 g/100g 41167-0338-00 | Chattem, | 1 bottle | — | — | FDA listed | — |
| anti itch 1 g/100g 41250-0369-16 | Meijer | 1 tube | — | — | Discontinued | — |
| Publix Hydro 1 g/100g 41415-0047-75 | Publix | 1 tube | — | — | FDA listed | — |
| Publix hydro plus 1 g/100g 41415-0048-75 | Publix | 1 tube | — | — | FDA listed | — |
| Hydrocortisone Cream 1% 1 g/100g 41415-0330-02 | Publix | 1 tube | — | — | FDA listed | — |
| careone anti itch 1 g/100g 41520-0033-64 | American | 1 tube | — | — | FDA listed | — |
| Care One hydrocortisone maximum strength 1 g/100g 41520-0319-64 | American | 1 tube | — | — | FDA listed | — |
| Anti Itch 1 g/100g 42507-0319-64 | HyVee | 1 tube | — | — | FDA listed | — |
| anti itch 1 g/100g 42507-0973-64 | HyVee | 1 tube | — | — | FDA listed | — |
| Xpect Hydrocortisone .01 g/g 42961-0237-02 | Cintas | 10 packets | — | — | FDA listed | — |
| Hydrocortisone 10 mg/g 43473-0049-01 | Nantong | 9 g | — | — | FDA listed | — |
| Aosi Healthcare 1 g/100g 43473-0054-01 | Nantong | 9 g | — | — | FDA listed | — |
| health beyond 1 g/100g 43473-0092-01 | Nantong | 9 g | — | — | FDA listed | — |
| SurviveX Hydrocortisone Cream 10 mg/g 43473-0313-01 | Nantong | 9 g | — | — | FDA listed | — |
| Avedana Hydrocortisone Cream with Aloe 10.2 mg/g 43749-0620-02 | Unipack | 1 tube | — | — | FDA listed | — |
| Kera Hc 1 g/100g 44577-0623-02 | Clinical | 56 g | — | — | FDA listed | — |
| Vanicream HC Anti-Itch 1.12 g/100g 45334-0327-02 | Pharmaceutical | 1 tube | — | — | FDA listed | — |
| Hydrocortisone with Aloe 1 g/100g 46122-0822-36 | AMERISOURCE | 1 tube | — | — | FDA listed | — |
| Medi-First Hydrocortisone 1% 10 mg/g 47682-0207-12 | Unifirst | 10 packets | — | — | FDA listed | — |
| Hydrocortisone 10 mg/g 47682-0211-12 | Unifirst | 10 pouches | — | — | FDA listed | — |
| Hydrocortisone 10 mg/g 47682-0397-35 | Unifirst | 144 packets | — | — | FDA listed | — |
| Green Guard Hydrocortisone 1% 10 mg/g 47682-0398-73 | Unifirst | 25 packets | — | — | FDA listed | — |
| Medi-First 1% Hydrocortisone 10 mg/g 47682-0923-73 | Unifirst | 25 packets | — | — | FDA listed | — |
| Hydrocortisone 10 mg/g 47682-0933-73 | Unifirst | 25 pouches | — | — | FDA listed | — |
| Medi-First Hydrocortisone 1% 10 mg/g 47682-0980-35 | Unifirst | 144 packets | — | — | FDA listed | — |
| Medi-First Plus Hydrocortisone 1% 10 mg/g 47682-0981-73 | Unifirst | 25 packets | — | — | FDA listed | — |
| equate hydrocortisone 1 g/100g 49035-0707-16 | Wal-Mart | 1 tube | — | — | Discontinued | — |
| Hydrocortisone anti-itch plus 10 mg/g 49035-0732-02 | Wal-Mart | 1 tube | — | — | FDA listed | — |
| Equate Hydrocortisone Intensive Healing Formula 1 g/100g 49035-0973-27 | Wal-Mart | 1 tube | — | — | FDA listed | — |
| Unishield 1% 1 g/100g 49314-0005-01 | Unishield | 25 packets | — | — | FDA listed | — |
| CeraVe Developed with Dermatologists Anti Itch 10 mg/g 49967-0108-01 | L'Oreal | 1 tube | — | — | FDA listed | — |
| Rugby Hydrocortisone With Aloe .01 g/g 50090-5470-00 | A-S | 1 tube | — | — | FDA listed | — |
| good sense anti itch 1 g/100g 50090-7255-00 | A-S | 1 tube | — | — | FDA listed | — |
| Hydrocortisone with Aloe 1 g/100g 50090-7428-00 | A-S | 1 tube | — | — | FDA listed | — |
| Live Better Hydrocortisone with Aloe 1 g/100g 51143-0059-02 | The | 1 tube | — | — | FDA listed | — |
| Hydrocortisone 10 mg/g 51316-0227-00 | CVS | 1 tube | — | — | FDA listed | — |
| Hydrocortisone 10 mg/g 51316-0230-00 | CVS | 1 tube | — | — | FDA listed | — |
| Aloe Cort .57 g/57g 51326-0108-57 | Topiderm, | 57 g | — | — | FDA listed | — |
| CAREALL Hydrocortisone Maximum Strength 1 g/g 51824-0050-01 | New | 28 g | — | — | FDA listed | — |
| CAREALL Hydrocortisone Maximum Strength .01 g/g 51824-0097-01 | New | 28 g | — | — | FDA listed | — |
| CAREALL Hydrocortisone Maximum Strength .01 g/g 51824-0098-14 | New | 144 packets | — | — | FDA listed | — |
| CAREALL Hydrocortisone Maximum Strength .01 g/g 51824-0197-02 | New | 72 tubes | — | — | FDA listed | — |
| Hydrocortisone Anti-Itch .01 g/g 52000-0022-37 | Universal | 1 tube | — | — | Discontinued | — |
| Anti-itch 10 mg/g 53329-0091-01 | Medline | 1 tube | — | — | FDA listed | — |
| Discount Drug Mart Anti-itch 1 g/100g 53943-0269-01 | DISCOUNT | 1 tube | — | — | FDA listed | — |
| DermaCort Anti-itch 10 mg/g 54473-0117-28 | Melaleuca, | 28 g | — | — | FDA listed | — |
| Exchange Select Hydrocortisone 1 g/100g 55301-0201-64 | Army | 1 tube | — | — | FDA listed | — |
| Freds Hydrocortisone with Aloe 1 g/100g 55315-0181-56 | FRED'S, | 1 tube | — | — | FDA listed | — |
| Freds Hydrocortisone Plus 12 Moisturizers 1 g/100g 55315-0182-56 | FRED'S, | 1 tube | — | — | FDA listed | — |
| Family Wellness Max Strength 1 Hydrocortisone Cream 10 mg/g 55319-0982-00 | Family | 1 tube | — | — | FDA listed | — |
| Thera Plus 1 g/100g 55621-0001-01 | Zhejiang | 28 g | — | — | FDA listed | — |
| Family Wellness 1 g/100g 55621-0008-01 | Zhejiang | 28 g | — | — | FDA listed | — |
| Assured 1 g/100g 55621-0018-28 | Zhejiang | 1 tube | — | — | FDA listed | — |
| ProCure Hydrocortisone 1% 1 g/100g 55681-0018-01 | Twin | 28.3 g | — | — | FDA listed | — |
| ProCure Hydrocortisone 1% 1 g/100g 55681-0019-14 | Twin | 144 packets | — | — | FDA listed | — |
| Rapidol 1 g/100g 55758-0420-03 | Pharmadel | 1 tube | — | — | FDA listed | — |
| rexall anti itch maximum strength relief 1 g/100g 55910-0225-64 | Dolgencorp, | 1 tube | — | — | FDA listed | — |
| DG Health Hydrocortisone Maximum Strength 1 g/100g 55910-0319-64 | Dolgencorp | 1 tube | — | — | FDA listed | — |
| DG health hydrocortisone 1 g/100g 55910-0504-16 | Dolgencorp, | 1 tube | — | — | FDA listed | — |
| Hydrocortisone 1% 1 g/100g 57896-0146-14 | Geri-Care | 144 packets | — | — | FDA listed | — |
| Hydrocortisone 1% 1 g/100g 58228-2045-02 | ProStat | 25 packets | — | — | FDA listed | — |
| PS-2896 Hydrocortisone Cream 1%, 0.9g 1 g/100g 58228-2896-01 | ProStat | 2000 packets | — | — | FDA listed | — |
| Hydrocortisone Cream 1% 1 g/100g 58228-6245-01 | Front | 25 packets | — | — | FDA listed | — |
| Hydrocortisone 1% 1 g/100g 58228-7020-01 | ProStat | 2000 packets | — | — | FDA listed | — |
| Hydrocortisone 1% 1 g/100g 58228-7030-01 | ProStat | 25 packets | — | — | FDA listed | — |
| Audiologist Anti-itch 1 g/100g 59256-0004-01 | OAKTREE | 1 tube | — | — | FDA listed | — |
| Quadrydern 10 mg/g 59428-0403-57 | Productos | 1 tube | — | — | FDA listed | — |
| CVS Cortisone 1 g/100g 59779-0099-02 | CVS | 1 tube | — | — | FDA listed | — |
| Hydrocortisone 10 mg/g 61010-5800-02 | Safetec | 144 pouches | — | — | FDA listed | — |
| TrueLipids 1% Hydrocortisone Barrier Cream 1 g/100g 61387-0252-01 | Claridei | 50 g | — | — | FDA listed | — |
| Hydrocortisone with Aloe 1 g/100g 63187-0504-01 | Proficient | 1 tube | — | — | FDA listed | — |
| Hydrocortisone 10 mg/g 63629-1951-01 | Bryant | 1 tube | — | AT | FDA listed | — |
| kirkland signature hydrocortisone plus maximum strength 1 g/100g 63981-0973-34 | Costco | 4 tubes | — | — | FDA listed | — |
| Proctocort 10 mg/g 65649-0501-30 | Salix | 1 tube | — | AT | Discontinued | — |
| Gelmicin Hydrocortisone with Aloe 1 g/100g 65923-0035-40 | United | 1 tube | — | — | FDA listed | — |
| Family Care Anti-Itch 1 g/100g 65923-0494-14 | United | 1 tube | — | — | FDA listed | — |
| Family Care Anti-Itch 1 g/100g 65923-0925-14 | United | 1 tube | — | — | FDA listed | — |
| WINCO Hydrocortisone 10 mg/g 67091-0055-28 | WinCo | 1 tube | — | — | FDA listed | — |
| Winco Maximum Strength Hydrocortisone 10 mg/g 67091-0197-28 | WINCO | 1 tube | — | — | FDA listed | — |
| WinCo Foods Hydrocortisone Cream Intensive Healing 10 mg/g 67091-0419-28 | WINCO | 1 tube | — | — | FDA listed | — |
| Natureplex Hydrocortisone Hydro .01 g/g 67234-0010-01 | Natureplex, | 28 g | — | — | FDA listed | — |
| Hydrocortisone 1 g/100g 67777-0004-01 | Dynarex | 1 tube | — | — | FDA listed | — |
| Hydrocortisone 1 g/100g 68016-0149-01 | Pharmacy | 1 tube | — | — | FDA listed | — |
| Hydrocortisone 1 g/100g 68016-0529-01 | Pharmacy | 1 tube | — | — | FDA listed | — |
| hydrocortisone 1 g/100g 68071-5205-01 | NuCare | 28 g | — | — | FDA listed | — |
| Hydrocortisone with Aloe 1 g/100g 68071-5305-01 | NuCare | 1 tube | — | — | FDA listed | — |
| members mark hydrocortisone 1 g/100g 68196-0973-34 | Sam's | 4 tubes | — | — | FDA listed | — |
| berkley and jensen anti itch 1 g/100g 68391-0100-16 | BJWC | 2 tubes | — | — | FDA listed | — |
| CliniCalm 1 g/100g 68726-0504-01 | CP | 7 g | — | — | FDA listed | — |
| Hydrocortisone 1% 1 g/100g 68788-4109-02 | Preferred | 1 tube | — | — | FDA listed | — |
| good sense anti itch 1 g/100g 68788-4122-02 | Preferred | 1 tube | — | — | FDA listed | — |
| hydrocortisone 1 g/100g 68788-8078-02 | Preferred | 1 tube | — | — | FDA listed | — |
| Hydrocortisone 1% with healing aloe 1 g/100g 69396-0005-05 | Trifecta | 1 tube | — | — | FDA listed | — |
| Hydrocortisone Cream 1 g/100g 69396-0028-01 | Trifecta | 1 tube | — | — | FDA listed | — |
| Hydrocortisone 1% 1 g/100g 69396-0050-01 | Trifecta | 1 tube | — | — | FDA listed | — |
| Hydrocortisone 1% 1 g/100g 69396-0055-01 | Trifecta | 1 tube | — | — | FDA listed | — |
| Itch Relief 1 g/100g 69396-0057-01 | Trifecta | 1 tube | — | — | FDA listed | — |
| Hydrocortisone 1% 1 g/100g 69396-0081-01 | Trifecta | 1 tube | — | — | FDA listed | — |
| Hydrocortisone Cream 1 g/100g 69396-0096-16 | Trifecta | 454 g | — | — | FDA listed | — |
| Hydrocortisone 1% 1 g/100g 69396-0118-09 | Trifecta | 144 packets | — | — | FDA listed | — |
| Hydrocortisone 1% 1 g/100g 69396-0129-01 | Trifecta | 1 tube | — | — | FDA listed | — |
| Hydrocortisone Cream 1 g/100g 69396-0147-01 | Trifecta | 1 tube | — | — | FDA listed | — |
| Alumier MD Intensive Recovery 10 mg/mL 69473-0017-01 | Alumier | 1 tube | — | — | FDA listed | — |
| Alumier MD Post Procedure Kit with Hydrocortisone 69473-0020-01 | Alumier | 1 kit | — | — | FDA listed | — |
| Family Wellness 1 g/100g 69571-0009-01 | FRONT | 1 tube | — | — | FDA listed | — |
| Barmicil Plus 10 mg/g 69729-0103-11 | OPMX | 28 g | — | — | FDA listed | — |
| Quatriderm Anti-itch 1 g/100g 69729-0269-53 | OPMX | 1 tube | — | — | FDA listed | — |
| Barmicil Anti-itch 1 g/100g 69729-0301-51 | OPMX | 1 tube | — | — | FDA listed | — |
| CVS Health Hydrocortisone Anti Itch 10 mg/g 69842-0155-10 | CVS | 24 packets | — | — | Discontinued | — |
| CVS Anti itch 1 g/100g 69842-0292-01 | CVS | 1 tube | — | — | FDA listed | — |
| Maximum Strength Cortisone Cream with Aloe 1 g/100g 69842-0630-03 | CVS | 1 tube | — | — | FDA listed | — |
| Aveeno Hydrocortisone ANTI-ITCH 10 mg/g 69968-0511-01 | Kenvue | 1 tube | — | — | FDA listed | — |
| Aveeno 1% Hydrocortisone Anti-Itch Cream 10 mg/g 69968-0888-01 | Kenvue | 1 tube | — | — | FDA listed | — |
| Ana Cool Rapid Soothing Cooling Formula 10 mg/g 70288-0714-01 | Ana-Cool, | 1 bottle | — | — | FDA listed | — |
| Post-Treatment Repair Cream 1 g/100mL 70484-0007-02 | Vi | 22 ml | — | — | FDA listed | — |
| Caring Mills Hydrocortisone 1 g/100g 71101-0021-01 | Veridian | 1 tube | — | — | FDA listed | — |
| TheraCare Hydrocortisone Cream 10 mg/g 71101-0220-01 | Veridian | 1 tube | — | — | FDA listed | — |
| hydrocortisone 1 g/100g 71205-0571-01 | Proficient | 1 tube | — | — | FDA listed | — |
| Hydrocortisone 1 mg/100g 71399-0180-01 | AKRON | 454 g | — | — | FDA listed | — |
| American Safety and First Aid 10 mg/g 71927-0031-02 | Orazen | 25 pouches | — | — | FDA listed | — |
| Medi-First 10 mg/g 71927-0032-02 | Orazen | 25 pouches | — | — | FDA listed | — |
| Medi First Plus 10 mg/g 71927-0033-02 | Orazen | 25 pouches | — | — | FDA listed | — |
| Hydrocortisone 10 mg/g 72162-1763-02 | Bryant | 1 tube | — | AT | FDA listed | — |
| hydrocortisone 1 g/100g 72162-2283-02 | Bryant | 1 tube | — | — | FDA listed | — |
| Hydrocortisone 10 mg/g 72189-0209-28 | DIRECT | 28.4 g | — | AT | FDA listed | — |
| Basic Care Hydrocortisone 1 g/100g 72288-0369-64 | Amazon.com | 1 tube | — | — | FDA listed | — |
| basic care hydrocortisone 1 g/100g 72288-0973-16 | Amazon.com | 1 tube | — | — | FDA listed | — |
| Hydrocortisone 10 mg/g 73141-0622-28 | A2A | 1 tube | — | — | FDA listed | — |
| Crane Safety Hydrocortisone 10 mg/g 73408-0933-73 | Crane | 25 packets | — | — | FDA listed | — |
| Thompson Hydrocortisone 1% 10 mg/g 73408-0937-73 | Thompson | 25 packets | — | — | FDA listed | — |
| Thompson Hydrocortisone 1% 10 mg/g 73408-0981-73 | Thompson | 25 packets | — | — | FDA listed | — |
| Gembooxt ECZEMA RELIEF Cream .01 g/g 76986-0019-01 | Guangdong | 2 bottles | — | — | FDA listed | — |
| Meijer Hydrocortsione Cream 1 g/100g 79481-0018-01 | Meijer | 1 tube | — | — | FDA listed | — |
| anti itch 1 g/100g 79481-0319-00 | Meijer, | 1 tube | — | — | FDA listed | — |
| anti itch 1 g/100g 79481-0973-00 | Meijer, | 1 tube | — | — | FDA listed | — |
| Equate Hydrocortisone Topical .01 g/g 79903-0091-01 | WalMart | 1 tube | — | — | FDA listed | — |
| Equate Hydrocortisone 10 mg/g 79903-0092-01 | WalMart | 1 tube | — | — | FDA listed | — |
| Hydrocortisone 10 mg/g 80489-0001-01 | OL | 1 tube | — | — | FDA listed | — |
| Thera plus Anti-itch with aloe Hydrocortisone 10 mg/g 80684-0038-01 | Fourstar | 1 tube | — | — | FDA listed | — |
| Thera Plus Maximum Strength Hydrocortisone 10 mg/g 80684-0145-00 | Fourstar | 42.5 g | — | — | FDA listed | — |
| Thera Plus Eczema Hydrocortisone Anti Itch 10 mg/g 80684-0146-00 | Fourstar | 28 g | — | — | FDA listed | — |
| Thera Plus Hydrocortisone Maximum Strength 10 mg/g 80684-0151-00 | FOURSTAR | 42.5 g | — | — | FDA listed | — |
| Thera Plus Maximum Strength Hydrocortisone 10 mg/g 80684-0197-00 | Fourstar | 6 packets | — | — | FDA listed | — |
| ZCort Ultra 10 mg/g 81335-0532-15 | RxDino, | 15 g | — | — | FDA listed | — |
| THERAPLEX AIM Anti-Itch Moisturizing 10 mg/g 82280-0478-02 | THERAPLEX, | 56.7 g | — | — | FDA listed | — |
| Westlake Anti-itch 1 g/100g 82895-0716-30 | Westlake | 1 tube | — | — | FDA listed | — |
| Hydrocortisone 10 mg/g 82942-1003-01 | J&A | 9 g | — | — | FDA listed | — |
| Anti-Itch with Aloe 1 g/100g 83324-0046-01 | Chain | 1 tube | — | — | FDA listed | — |
| Quality Choice 10 mg/g 83324-0297-01 | Chain | 1 tube | — | — | FDA listed | — |
| Hydrocortisone 1% 1 g/100g 83324-0329-01 | Chain | 1 tube | — | — | FDA listed | — |
| Bloop Itch Soothing Topical 1 g/100g 83838-0415-01 | Three | 1 tube | — | — | FDA listed | — |
| Itch and Rash Cream 10 mg/g 84269-4506-01 | Wildman | 25 packets | — | — | FDA listed | — |
| Hydrocortisone 10 mg/g 84387-0005-01 | ALLIED | 28.4 g | — | — | FDA listed | — |
| Hydrocortisone 1 g/100g 84722-3031-01 | VIVE | 4 g | — | — | FDA listed | — |
| Serynth Eczema Relief 1 g/100g 85248-0104-01 | Jiangxi | 20 g | — | — | FDA listed | — |
| DERMFREE Anti-itch 1 g/100g 85248-0126-01 | Jiangxi | 42.5 g | — | — | FDA listed | — |
| NATUHEAL RELIEF Cream FOR ECZEMA 1 g/100g 85248-0157-01 | Jiangxi | 20 g | — | — | FDA listed | — |
| Drmitsui Eczema Relief 1 g/100g 85248-0181-01 | Jiangxi | 20 g | — | — | FDA listed | — |
| Hydrocortisone 1 g/100g 85402-0001-01 | Medrock | 1 tube | — | — | FDA listed | — |
| hydrocortisone 1 g/100g 85766-0151-28 | Sportpharm | 1 tube | — | — | FDA listed | — |
| Hydrocortisone 10 mg/g 85766-0166-10 | Sportpharm | 10 pouches | — | — | FDA listed | — |
| Proheal Hydrocortisone 1% Maximum Strength Plus Aloe 1 g/100g 86173-0005-04 | Click | 113 g | — | — | FDA listed | — |
| zourunan Relieve itching cream ANTIFUNGAL 1 g/100g 87083-0003-01 | Guchutang | 20 g | — | — | FDA listed | — |
| Absolut Skin Corticosoothe Anti-Itch 10 mg/mL 87184-0899-00 | Absolut | 1 tube | — | — | FDA listed | — |
| Hydrocortisone with Aloe 1 g/100g 87236-0003-01 | Aldermed | 1 tube | — | — | FDA listed | — |
| Hydrocortisone 1 g/100g 87236-0004-09 | Aldermed | 144 packets | — | — | FDA listed | — |
| DERMFREE Anti-itch Cream 1 g/100g 87686-0001-01 | Jiangxi | 42.5 g | — | — | FDA listed | — |
| SKIN A COOL Hydrocortisone Anti-Itch 10 mg/g 70288-0173-00 | Ana-Cool, | 56.7 g | — | — | FDA listed | — |
| Cortizone 10 Cooling Relief 10 mg/g 41167-0036-00 | Chattem, | 1 tube | — | — | FDA listed | — |
| Viaderma Calm Anti-Itch 10 mg/g 71262-0014-15 | ViaDerma | 1 bottle | — | — | FDA listed | — |
| Cortizone 10 Intensive Healing for Eczema 10 mg/g 41167-0331-00 | Chattem, | 1 tube | — | — | FDA listed | — |
| Preparation H Soothing Relief Anti-Itch 10 mg/g 00573-0552-11 | Haleon | 1 tube | — | — | FDA listed | — |
| Preparation H Hydrocortisone 10 mg/g 00573-2830-10 | Haleon | 1 tube | — | — | FDA listed | — |
| FifthPulse Hydrocortisone 10 mg/g 87525-0003-01 | WeCare | 1 tube | — | — | FDA listed | — |
| Hydrocortisone 1% Anti-ItchCream 10 mg/g 00924-5634-00 | Acme | 9 g | — | — | FDA listed | — |
| Drs. Hydrocortisone Aloe Vera 10 mg/g 80489-0088-01 | OL | 1 tube | — | — | FDA listed | — |
| Quadriderm NF 10 mg/g 69729-0828-02 | OPMX | 1 tube | — | — | FDA listed | — |
| Diprospan 10 mg/g 69729-0794-02 | OPMX | 1 tube | — | — | FDA listed | — |
| Barmicil Plus 10 mg/g 69729-0830-01 | OPMX | 1 tube | — | — | FDA listed | — |
| Aerosoothe 10 mg/g 55305-0136-02 | Aero | 25 packets | — | — | FDA listed | — |
| Barmicil Plus 10 mg/g 69729-0834-01 | OPMX | 1 tube | — | — | FDA listed | — |
| Terramed Just Think Comfort Hydrocortisone 1% Cream 10 mg/g 83004-0051-01 | Rida | 1 jar | — | — | FDA listed | — |
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA Orange Book · refreshed Sep 3, 2026
- CMS NADAC weekly file · file of Sep 30, 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 Sep 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.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
-
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 5ZA2S6B08X
Cetyl palmitate is a waxy substance made from natural fats. It works as a binder and thickener to help hold the medicine together and control how it dissolves in your body.
-
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.
-
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 368GB5141J
A detergent and foaming agent derived from coconut or palm oil. In medications, it helps break down and mix oil and water-based ingredients, aids in tablet disintegration, and improves how the drug dissolves and spreads in the mouth or digestive system.
-
UNII X045WJ989B
Sorbic acid is a preservative derived from berries that prevents mold, yeast, and bacterial growth in medicines. It keeps the product stable and safe 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.
8 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 1, 2026
- FDA openFDA NDC Directory · synced Oct 1, 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
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 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 from two to four 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. To report SUSPECTED ADVERSE REACTIONS, contact ANI Pharmaceuticals, Inc. at 1-855-204-1431 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
🤰 Pregnancy ▾
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 ▾
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 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 systems effects (See PRECAUTIONS ).
🧬 Clinical Pharmacology ▾
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.
(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, 1% is supplied in: 1 oz (28.4 grams) tube NDC 62559-430-01 Hydrocortisone Cream USP, 2.5% is supplied in: 30 grams tube NDC 62559-431-30 Manufactured by: Crown Laboratories, Inc., Johnson City, Tennessee 37604 Distributed by: ANI Pharmaceuticals, Inc. Baudette, MN 56623 PRINTED IN USA P4624.03 Rev 05/25
📦 Storage and Handling ▾
PACKAGING AND STORAGE Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
📋 Description ▾
DESCRIPTION: The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and antipruritic agents. Hydrocortisone is a member of this class. Chemically hydrocortisone is pregn-4-ene-3, 20-dione, 11, 17, 21-trihydroxy-, (11β)-.
Its molecular formula is C 21 H 30 O 5 and molecular weight is 362.47. Its structural formula is: Each gram of Hydrocortisone Cream USP, 1% contains 10 mg hydrocortisone USP in a cream base consisting of purified water, cetyl alcohol, glycerin, stearyl alcohol, propylene glycol, sodium lauryl sulfate, cetyl palmitate and sorbic acid. Each gram of Hydrocortisone Cream USP, 2.5% contains 25 mg hydrocortisone USP in a cream base consisting of purified water, cetyl alcohol, glycerin, stearyl alcohol, propylene glycol, sodium lauryl sulfate, cetyl palmitate and sorbic acid. 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 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 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 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.
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 demonstr… [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.
🧬 Pharmacokinetics ▾
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.
📄 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 Display Panel Hydrocortisone Cream USP, 1% NDC 62559-430-01 Rx only 1 oz (28.4 grams) carton-1
Package/Label Display Panel Hydrocortisone Cream USP, 2.5% NDC 62559-431-30 Rx only 30 grams carton-2