Hydrocortisone Cream

Manufacturer
McKesson | Ultra Seal Corporation
Effective date
2023-01-05
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
legacy-cache
Hydrated at
2026-08-01 21:41:32

Label at a glance#

ProductHydrocortisone
Active ingredientHYDROCORTISONE
Label structure14 sections

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Hydrocortisone Cream 1%

Active Ingredients (in each gram)

Hydrocortisone USP 10 mg

OTC - PURPOSE SECTION

Purpose

Antipruritic (Anti Itch)

INDICATIONS & USAGE SECTION

Indications:
For the temporary relief of itching associated with minor skin irritation and rashes due to eczema, insect bites, poison ivy, poison oak, poison sumac, soaps, detergents, cosmetics, jewelry, seborrheic dermatitis, psoriasis scrapes
For the temporary relief of external genital, feminine and anal itching
Other uses of this product should be only under the advice and supervision of a doctor

WARNINGS SECTION

Warnings:
For external use only

  • Avoid contact with eyes
  • Do not exceed the recommended daily dosage unless directed by a doctor
  • Do no use for treatment of diaper rash
  • In case of bleeding, consult a doctor promptly

Consult a doctor:

  • Before use if you have a vaginal discharge (for external feminine itching)
  • For external itching, do not exceed the recommended daily dosage or if bleeding occurs
  • If condition worsens or if symptoms persist for more than 7 days or clear up and occur again within a few days discontinue use of this product

When using this product:

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

OTC - STOP USE SECTION

Do Not Use:

  • With any other Hydrocortisone product unless you have consulted a doctor

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

DOSAGE & ADMINISTRATION SECTION

Directions:

  • For adults and children 2 years of age and older: apply externally to affected area not more than 3 to 4 times daily.
  • Children under 2 years of age: do not use, consult a doctor
  • Adults for external anal itching when practical, cleanse the affected area with mild soap and warm water and rinse thoroughly, or by patting or blotting with appropriate cleansing pad. Gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product.
  • Children under 12 years or age; for external anal itching, consult a doctor.

OTHER SAFETY INFORMATION

Other Information:

  • Store at controlled room temperature 59* to 86*F (15* to 30*C)
  • Avoid excessive heat and humidity
  • Tamper Evident. Do not use if packet is torn, cut or opened

INACTIVE INGREDIENT SECTION

Inactive Ingredients:
Benzoic acid, chlorphenesin, citric acid, glycerin, glyceryl monostearate, methylparaben, mineral oil, petrolatum, phenoxyethanol, polysorbate 80, purified water, titanium dioxide, trisodium citrate.

OTC - QUESTIONS SECTION

Questions? Call 1-800-777-4908

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 68599-1182-2
Hydrocortisone Cream 1%
Maximum Strength
Effective itch and rash relief cream.
NET WEIGHT
0.9 g (0.03 oz)

MFR # 118-82464

118-82464 Each118-82464 Each

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 68599-1182-2
McKesson
Hydrocortisone Cream 1%
Maximum Strength
NET WEIGHT
0.9 g (0.03 oz)
144 PACKS PER BOX
MFR # 118-82464

118-82464 Box118-82464 Box

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL


NDC 68599-1182-2
McKesson
Hydrocortisone Cream 1%
Maximum Strength
NET WEIGHT
0.9 g (0.03 oz)
144 PACKS PER BOX
12 BOXES PER CASE
MFR # 118-82464

118-82464 Case118-82464 Case

Products#

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NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68599-118268599-1182-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 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
f18aa597-e5af-3d56-e053-2a95a90a623080d8fb8c-8e76-937d-e053-2a91aa0a96652023-01-05WarningsExact identifier
spl id: f18aa597-e5af-3d56-e053-2a95a90a6230
spl set id: 80d8fb8c-8e76-937d-e053-2a91aa0a9665

Reported adverse events (FAERS/openFDA)#

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