Indications and uses
For temporary relief of itching associated with minor skin irritations and rashes ● external feminine, genital and anal itching Other uses of this product should be only under the advice and supervision of a doctor
Globe Hydrocortisone Cream 1% MAXIMUM STRENGTH
- Manufacturer
- Trifecta Pharmaceuticals Usa Llc
- Effective date
- 2026-03-04
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 5
- Source
- full-release
- Hydrated at
- 2026-06-01 01:48:58
Label at a glance#
ProductHydrocortisone 1%
Active ingredientHYDROCORTISONE
Label structure15 sections
Dosage and administration
Adults and children 2 years of age and older: apply to the affected area not more than 3 to 4 times daily. Children under 2 years of age: do not use and ask a doctor. For External and anal itching in adults: When practical, clean affected area with mild soap and warm water and rinse thoroughly Gently dry by patting or blotting with toilet tissue or a soft cloth before applying For External anal and genital itching...
Storage and handling
● store at controlled room temperature 20°-25°C ( 68 °- 77 °F) Tamper evident, do not use if packet is torn, cut or opened. Avoid excessive heat and humidity.
Contacts and useful links#
Websitewww.trifecta-pharma.com
www.trifecta-pharma.com
www.trifecta-pharma.comLabel contents#
Full prescribing information#
Active ingredient
Hydrocortisone 1%
Purpose
Antipruritic (Anti-Itch)
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of the reach of children.
If swallowed, get medical help or contact a Poison Control Center immediately.
Uses
For temporary relief of itching associated with minor skin irritations and rashes
● external feminine, genital and anal itching
Other uses of this product should be only under the advice and supervision of a doctor
Do Not Use
- For the treatment of diaper rash, consult a doctor.
- With any other Hydrocortisone product unless you have consulted a doctor
- If you have a vaginal discharge, consult a doctor
Warnings
For external use only
When using this product
- Avoid Contact with the eyes
- do not exceed the recommended daily dosage unless directed by a doctor.
- do not put this product into the rectum by using fingers or any mechanical device or applicator.
Stop using this product and ask a doctor if
- conditions worsens, symptoms persist for more than 7 days or symptoms clear up and reappear again within a few days and do not begin use of any other hydrocortisone product.
- Rectal bleeding occurs
Directions
Adults and children 2 years of age and older: apply to the affected area not more than 3 to 4 times daily.
Children under 2 years of age: do not use and ask a doctor.
For External and anal itching in adults:
When practical, clean affected area with mild soap and warm water and rinse thoroughly
Gently dry by patting or blotting with toilet tissue or a soft cloth before applying
For External anal and genital itching in children under 12 years of age:
Ask a doctor
Inactive ingredients
Ceteareth-20, Cetearyl alcohol, Ethylhexylglycerin, Glycerin, Glyceryl Stearate, mineral oil, petrolatum, Phenoxyethanol, water.
Other information
● store at controlled room temperature 20°-25°C ( 68 °- 77 °F)
Tamper evident, do not use if packet is torn, cut or opened.
Avoid excessive heat and humidity.
SPL UNCLASSIFIED SECTION
Distributed by:
Trifecta Pharmaceuticals USA™
Ft. Lauderdale, FL 33301 USA
Online: www.trifecta-pharma.com
Reorder No. 1016SL
To reorder call: 1-888-296-9067
Fax: 888-878-3609
Questions
Call 1-888-296-9067
LABEL
Packaging
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 106258 | hydrocortisone 1 % Topical Cream | PSN | 5 |
| 106258 | hydrocortisone 10 MG/ML Topical Cream | SCD | 5 |
| 106258 | hydrocortisone 1 % (as hydrocortisone acetate 1.2 % ) Topical Cream | SY | 5 |
| 106258 | hydrocortisone 1 % Topical Cream | SY | 5 |
| 106258 | hydrocortisone 1 GM per 100 GM Topical Cream | SY | 5 |
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| HYDROCORTISONE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
Product Linked Resources#
| Resource | Code type | Value | Equivalent identifiers | Source image |
|---|---|---|---|---|
| Barcode | EAN-13 | 0850026393767 | GTIN-13: 0850026393767 EAN-13: 0850026393767 GTIN-12: 850026393767 UPC-A: 850026393767 GTIN storage (14 digits): 00850026393767 | 1016SL GLOBE HYDROCORTISONE CREAM WITHOUT ALOE 0.9G 144CT 073125 CDER.jpg |
| Barcode | EAN-13 | 0850026393774 | GTIN-13: 0850026393774 EAN-13: 0850026393774 GTIN-12: 850026393774 UPC-A: 850026393774 GTIN storage (14 digits): 00850026393774 | Globe Hydrocortisone Cream 0.9g 25pks CDER.jpg |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 69396-118-09 | Hydrocortisone 1% | 144 in 1 CARTON | CREAM | 144 | 5 | |
| 69396-118-09 | Hydrocortisone 1% | 0.9 g in 1 PACKET | CREAM | 0.9 | 5 | |
| 69396-118-25 | Hydrocortisone 1% | 25 in 1 BOX | CREAM | 25 | 5 | |
| 69396-118-25 | Hydrocortisone 1% | 0.9 g in 1 PACKET | CREAM | 0.9 | 5 |
Products#
Every source-derived product name is available through these pages.
- Hydrocortisone 1%
- Hydrocortisone
- PHENOXYETHANOL
- MINERAL OIL
- GLYCERIN
- GLYCERYL MONOSTEARATE
- PETROLATUM
- WATER
- POLYOXYL 20 CETOSTEARYL ETHER
- CETOSTEARYL ALCOHOL
- ETHYLHEXYLGLYCERIN
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 69396-118 | 69396-118-09, 69396-118-25 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| PHENOXYETHANOL | HIE492ZZ3T | IACT |
| MINERAL OIL | T5L8T28FGP | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| GLYCERYL MONOSTEARATE | 230OU9XXE4 | IACT |
| PETROLATUM | 4T6H12BN9U | IACT |
| WATER | 059QF0KO0R | IACT |
| HYDROCORTISONE | WI4X0X7BPJ | ACTIB |
| POLYOXYL 20 CETOSTEARYL ETHER | YRC528SWUY | IACT |
| CETOSTEARYL ALCOHOL | 2DMT128M1S | IACT |
| ETHYLHEXYLGLYCERIN | 147D247K3P | IACT |
Source Document#
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Hydrocortisone 1% | HYDROCORTISONE | Trifecta Pharmaceuticals Usa Llc | f4d4a56b-b4b7-9a07-e053-2a95a90ad853 | 2026-03-04 | Warnings | 69396-118-09 69396-118-25 69396-118 69396011825 69396011809 4c35f112-b0b8-2efb-e063-6394a90a8f5b f4d4a56b-b4b7-9a07-e053-2a95a90ad853 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.