RUGBY ® HYDROCORTISONE CREAM 1% WITH ALOE

Manufacturer
RUGBY | Natureplex LLC
Effective date
2024-12-31
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 20:43:51

Label at a glance#

ProductRUGBY HYDROCORTISONE WITH ALOE
Active ingredientHYDROCORTISONE
Label structure11 sections

Indications and uses

for the temporary relief of itching associated with minor skin irritations, inflammation, and rashes due to eczema, insect bites, poison ivy, poison oak, poison sumac, soaps, detergents, cosmetics, jewelry and for external anal and genital itching.

Dosage and administration

For itching associated with minor skin irritations, inflammation, and rashes: Adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily Children under 2 years of age: Consult a doctor For external anal and genital itching: Adults and children 12 years of age and older: when practical, cleanse the affected area with mild soap or warm water and rinse thoroughly or by patti...

Storage and handling

Store at 15 to 30°C (59 to 86°F). Tamper Evident: DO NOT USE IF SEAL ON TUBE IS BROKEN OR MISSING.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Hydrocortisone 1%

Purpose

OTC - PURPOSE SECTION

Antipruritic (anti-itch)

Uses

INDICATIONS & USAGE SECTION

  • for the temporary relief of itching associated with minor skin irritations, inflammation, and rashes due to eczema, insect bites, poison ivy, poison oak, poison sumac, soaps, detergents, cosmetics, jewelry
  • and for external anal and genital itching.

Warnings

WARNINGS SECTION

For external use only.

Avoid contact with eyes.

Do not use

OTC - DO NOT USE SECTION

  • if you have a vaginal discharge. Consult a doctor.

When using this product

OTC - WHEN USING SECTION

  • do not exceed the recommended daily dosage unless directed by a doctor
  • do not put into the rectum by using fingers or any mechanical device or applicator

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • condition worsens
  • symptoms persist for more than 7 days or clear up and occurs again within a few days
  • bleeding occurs

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

DOSAGE & ADMINISTRATION SECTION

For itching associated with minor skin irritations, inflammation, and rashes:

Adults and children 2 years of age and older:

  • apply to affected area not more than 3 to 4 times daily

Children under 2 years of age: Consult a doctor

For external anal and genital itching:

Adults and children 12 years of age and older:

  • when practical, cleanse the affected area with mild soap or warm water and rinse thoroughly or by patting or blotting with an appropriate cleansing pad
  • gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product
  • apply to affected area not more than 3 to 4 times daily

Children under 12 years of age: Consult a doctor

Other information

STORAGE AND HANDLING SECTION

Store at 15 to 30°C (59 to 86°F).

Tamper Evident: DO NOT USE IF SEAL ON TUBE IS BROKEN OR MISSING.

Inactive ingredients

INACTIVE INGREDIENT SECTION

aloe barbadensis leaf juice, carbomer, cetyl alcohol, DMDM hydantoin, glyceryl stearate, isopropyl alcohol, methylparaben, mineral oil, polysorbate-20, propylparaben, purified water, stearic acid, triethanolamine, trisodium EDTA

Questions or comments?

OTC - QUESTIONS SECTION

1-800-645-2158

SPL UNCLASSIFIED SECTION

Distributed by:
RUGBY® LABORATORIES
17177 N Laurel Park Drive, Suite 233
Livonia, MI 48152
www.rugbylaboratories.com

PRINCIPAL DISPLAY PANEL - 28 g Tube Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Rugby®
NDC 0536-1277-80

Maximum Strength

Hydrocortisone Cream 1%
with Aloe

Compare to the
active ingredient of
Cortizone-10® with Aloe*

Fast itch relief

NET WT 1 OZ (28 g)

PRINCIPAL DISPLAY PANEL - 28 g Tube Carton
PRINCIPAL DISPLAY PANEL - 28 g Tube Carton

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0536-1277RUGBY HYDROCORTISONE WITH ALOE (HYDROCORTISONE) CREAM [RUGBY]3Legacy NDC20250101_796e792b-20c4-4a43-b7a2-55d31ee04092.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0536-12770536-1277-80

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Source Document#

Source XML

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.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
a90f6dfc-c7bc-4ead-8492-e27233742cd4796e792b-20c4-4a43-b7a2-55d31ee040922025-09-16WarningsExact identifier
spl set id: 796e792b-20c4-4a43-b7a2-55d31ee04092

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.