Hydrocortisone Cream 1%

Manufacturer
SOLA Pharmaceuticals
Effective date
2022-07-05
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-05-31 23:50:04

Label at a glance#

ProductHydrocortisone Cream 1%
Active ingredientHYDROCORTISONE
Label structure9 sections

Indications and uses

Relieves itches and rashes due to: Eczema Psoriasis Seborrheic dermatitis Poison ivy Poison oak Poison sumac Insect bites External anal itching Soaps Detergents Cosmetics Jewelry Temporary relief of external anal and genital itching. Other use of the product should only be under the advice and supervision of a doctor.

Dosage and administration

Adults and children over 2 years of age - Apply to affected area not more than 3-4 times per day. Children under 2 years of age - Do not use. Consult a doctor. For external anal itching Adults - When practical cleanse the affcted area with mild soap and water and rinse thoroughly. Gently dry patting with bathroom tissue or soft cloth before applying. ​Apply to affected area not more than 3-4 times per day. Childre...

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Hydrocortisone 1%

Purpose

OTC - PURPOSE SECTION

Antipruritic (Anti-itch)

Uses

INDICATIONS & USAGE SECTION

Relieves itches and rashes due to:

  • Eczema
  • Psoriasis
  • Seborrheic dermatitis
  • Poison ivy
  • Poison oak
  • Poison sumac
  • Insect bites
  • External anal itching
  • Soaps
  • Detergents
  • Cosmetics
  • Jewelry

Temporary relief of external anal and genital itching.

Other use of the product should only be under the advice and supervision of a doctor.

Warnings

WARNINGS SECTION

For external use only

Do not use:

  • In the eyes
  • For diaper rash
  • If you have vaginal discharge
  • More than the recommended dosage

Ask doctor before use:

  • If you are pregnant or breast feeding

Stop use and ask a doctor if:

  • Condition worsens, or is 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.

​When using this product:

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact Poison Control Center right away

Directions

DOSAGE & ADMINISTRATION SECTION

  • Adults and children over 2 years of age - Apply to affected area not more than 3-4 times per day.
  • Children under 2 years of age - Do not use. Consult a doctor.
    • For external anal itching Adults - When practical cleanse the affcted area with mild soap and water and rinse thoroughly. Gently dry patting with bathroom tissue or soft cloth before applying. ​Apply to affected area not more than 3-4 times per day. Children under 12 years of age: consult a doctor.

Other Information

OTHER SAFETY INFORMATION

  • store between 20ºC and 25ºC (68ºFk and 77ºF)
  • avoid excessive heat and humidity

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Cetomacrogol 1000, Cetostearyl alcohol, Chlorocresol, Disodium EDTA, Liquid paraffin, Propylene glycol, Purified water, Sodium metabisulphite, White soft paraffin.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Questions of comments? Call 1-866-747-7365

Manufactured for : SOLA Pharmaceuticals

Baton Rouge, LA 70810


Store in a dry, cool place

Hydrocortisone 1% Cream

NDC 70512-101-30


Qty: 28.4g

Hydrocortisone boxHydrocortisone boxHydrocortisone TubeHydrocortisone Tube

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1043690hydrocortisone acetate 1 % Topical CreamPSN4
1043690hydrocortisone acetate 10 MG/ML Topical CreamSCD4
1043690hydrocortisone acetate 1 % Topical CreamSY4

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
HYDROCORTISONE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
15bd4439-874a-4934-9954-248e5455d460Product name120260310
9962b773-9f2e-22cc-0032-535e48ac417bProduct name320250724
56bb0587-1bf2-48b2-9d93-fc9f59d1eeb2Product name120250325
4d56e8eb-d741-d4a5-de3f-2bab1af75a60Product name720220608
626d7260-31b5-4412-84fd-579746adb6b3Product name120210513
8a011600-5e61-4c59-ab7b-54ab658a3b71Product name220181127
a919621a-248d-3c7a-1084-9f9ce286fdfdProduct name220181009
e7d5a174-836b-a0af-b014-cb0826c69ddcProduct name220181004
fcce390d-6460-4701-87cf-940d8800a1c3Product name220180212
bf065fa6-1e3b-e4c3-0bde-2dc842ceeea1Product name220150218
02657a3f-1489-66ea-f740-5ab9524e57d7Product name120140508
26f3d783-2cc1-4327-e77d-71804cf675a2Product name120140508
36fdc54c-bbeb-981e-8a53-4d768e283892Product name120140508
58f3f9b7-3b9b-a9c1-1c9f-18ac777192b8Product name120140508
61e59a42-186b-9f4b-aec3-fb49a6debc31Product name120140508
705740e1-dee5-2610-c5a3-4c59cd9d62afProduct name120140508
7bdc4804-3832-c0df-e519-72b6d47c9792Product name120140508
a7051cba-790b-a699-81f8-dbbbdbd9b5acProduct name120140508
abaf203f-619e-f265-559f-8c81af5cb1c2Product name120140508
acc4d8bb-0e29-e9f8-65f8-31e94184a9c0Product name120140508
b045ad64-0f28-9a02-2f9b-b34d94fb2278Product name120140508
bfd28ffb-d550-3fe9-f65b-10bcb7f971fdProduct name120140508
da108d9e-edc8-17a3-8c28-3251c6a8acccProduct name120140508
fe21f3fd-a378-0654-1972-db3c3b64470eProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70512-101-302024-01-30C16284748780-11030e365-4f26-111a-e063-dadaa90a10e2Hydrocortisone Cream 1%

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70512-101-30Hydrocortisone Cream 1%1 in 1 CARTONCREAM14
70512-101-30Hydrocortisone Cream 1%30 g in 1 TUBECREAM304

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70512-101HYDROCORTISONE CREAM 1% CREAM [SOLA PHARMACEUTICALS]4Legacy NDC, 2 package rows20220706_a36b9275-fc3f-106a-e053-2a95a90a3beb.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70512-101-30GM - Gram70512-10163cc083c-6e85-434c-9785-501ae92e4f1212020-08-06

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70512-10170512-101-30

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 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
e314cc52-3f73-9a9c-e053-2a95a90a3f4aa36b9275-fc3f-106a-e053-2a95a90a3beb2022-07-05WarningsExact identifier
spl id: e314cc52-3f73-9a9c-e053-2a95a90a3f4a
spl set id: a36b9275-fc3f-106a-e053-2a95a90a3beb

Reported adverse events (FAERS/openFDA)#

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