OLP Hydrocortisone 1%

Manufacturer
OHIO LAB PHARMA
Effective date
2018-11-26
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
legacy-cache
Hydrated at
2026-08-02 00:45:35

Label at a glance#

ProductOLP Hydrocortisone 1%
Active ingredientHYDROCORTISONE
Label structure13 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 ...

Dosage and administration

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 •do not use, consult a doctor For external anal itching Adults: when practical, clean the affected area with mild soap and warm water, rinse thoroughly, gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product Children under 12 years of a...

Storage and handling

Store at room temperature 59°-86°F (15°-30°C). Protect from freezing. Before using any medication, read all label directions. Keep carton, it contains important information.

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

Hydrocortisone, USP 1%

PURPOSE

OTC - PURPOSE SECTION

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 ...

WARNINGS

WARNINGS SECTION

For external use only

DO NOT USE

OTC - DO NOT USE SECTION

  • for external feminine itching if you have a vaginal discharge. Consult a doctor.
  • for the treatment of diaper rash. Consult a doctor.

WHEN USING THIS PRODUCT

OTC - WHEN USING SECTION

•avoid contact with the eyes •do not begin the use of any other hydrocortisone product unless directed by a doctor

•for external anal itching: •do not use more than directed unless directed by a doctor

•do not put this product into the rectum by using fingers or any mechanical device or applicator

STOP USE AND ASK YOUR DOCTOR IF

OTC - STOP USE SECTION

•symptoms last for more than 7 days •the condition gets worse •symptoms clear up and occur again in a few days •rectal bleeding occurs, consult doctor promptly

KEEP OUT OF REACH OF CHILDREN

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 right away.

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

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 •do not use, consult a doctor
For external anal itching
Adults: when practical, clean the affected area with mild soap and warm water, rinse thoroughly, gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product
Children under 12 years of age: consult a doctor

OTHER INFORMATION

STORAGE AND HANDLING SECTION

Store at room temperature 59°-86°F (15°-30°C). Protect from freezing.
Before using any medication, read all label directions. Keep carton, it contains important information.

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

cetostearyl alcohol, sodium cetostearyl sulfate, stearic acid, trolamine, decyl oleate, propylene glycol, water, methyl paraben, propyl paraben, EDTA, vitamin E

QUESTIONS

OTC - QUESTIONS SECTION

ghassan@ohiolabpharma.com

PACKAGE LABEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

hydrocortisonehydrocortisone

EXTRA STRENGHT

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70648-002-012020-08-25C16284748780-19d75b9cf-cdca-f424-e053-dadaa90a57ce3a9f578f-ded7-0361-e054-00144ff88e88
70648-002-012020-01-31C16284748780-19d75b9cf-cdca-f424-e053-dadaa90a57ce3a9f578f-ded7-0361-e054-00144ff88e88

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70648-00270648-002-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 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
ada493cd-68ff-2605-e053-2a95a90ab9113a9f578f-ded7-0361-e054-00144ff88e882020-08-24WarningsExact identifier
spl set id: 3a9f578f-ded7-0361-e054-00144ff88e88

Reported adverse events (FAERS/openFDA)#

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