Hydrocortisone

Manufacturer
NeilMed Pharmaceuticals Inc
Effective date
2023-08-21
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 21:27:00

Label at a glance#

ProductHydrocortisone
Active ingredientHYDROCORTISONE
Label structure12 sections

Dosage and administration

Directions ■ for itching of skin irritation, 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: ask a doctor ■ If pregnant or breast-feeding: ask a health professional before use. ■ for external anal and genital itching, adults: ■ when practical, clean the affected area with mild soap and warm water and ...

Label contents#

Full prescribing information#

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients

Hydrocortisone 1%

Drug Facts

OTC - PURPOSE SECTION

Purpose : Anti-itch

Drug Facts

INDICATIONS & USAGE SECTION

Uses:

■ temporarily relieves itching associated with minor skin irritations, inflammation and rashes due to: ■ eczema ■ psoriasis ■ poison ivy, oak and sumac ■insect bites ■ detergents ■ jewelry ■ cosmetics ■ soaps ■ seborrheic dermatitis ■ temporarily relieves external anal and genital itching ■ other uses of this product should oonly be under the advise and supervison of a doctor

Warnings: For external use only

WARNINGS SECTION

Warnings: For external use only

Do not use

OTC - DO NOT USE SECTION

Do not use

■ in the genital area 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

When using this product

■ avoid contact with eyes ■ do not use more than directed unless told to do so by a doctor ■ do not put directly into the rectum by using fingers or any mechanical device or applicator

Stop use and ask a doctor if

OTC - STOP USE SECTION

Stop use and ask a doctor if ■ condition worsens, symptoms persist for more than 7 days or clear up and occur again within a few days, and do not begin use of any other hydrocortisone product unless you have asked a doctor. ■ rectal bleeding occurs

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. 1-800-222-1222

Directions

DOSAGE & ADMINISTRATION SECTION

Directions ■ for itching of skin irritation, 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: ask a doctor ■ If pregnant or breast-feeding: ask a health professional before use. ■ for external anal and genital itching, adults: ■ when practical, clean the 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 ■ apply to affected area not more than 3 to 4 times daily ■ children under 12 years of age: ask a doctor

Inactive ingredients:

INACTIVE INGREDIENT SECTION

Aloe extract, ascorbic acid, benzyl alcohol, ceteareth 20, cetearyl alcohol, cetyl palmitate, chamomile extract, glycerin, isopropyl myristate, isostearyl neopentanoate, methylparaben, PEG-40 stearate, petrolatum, purified water, sd 40 alcohol, vitamin A, vitamin D and vitamin E

SAFE HANDLING WARNING SECTION

TAMPER EVIDENT DO NOT USE IF SEAL ON TUBE IS PUNCTURED OR MISSING

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Cool relief gelCool relief gel

Products#

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NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
13709-31813709-318-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 19 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
1dd2cdce-70e3-ba08-e063-6294a90a2b30032fedc7-16d3-aa9c-e063-6294a90aa4452024-07-22WarningsExact identifier
spl set id: 032fedc7-16d3-aa9c-e063-6294a90aa445

Reported adverse events (FAERS/openFDA)#

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