CVS Health Maximum Strength Hydrocortisone

Manufacturer
CVS Health | Sheffield Pharmaceuticals LLC
Effective date
2024-08-02
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:16:32

Label at a glance#

ProductCVS Health Maximum Strength Hydrocortisone
Active ingredientHYDROCORTISONE
Label structure12 sections

Indications and uses

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

Dosage and administration

adults and children 2 years of age and older: apply to affected area not more than 3 to 4 time daily children under 2 years of age: ask a doctor for external anal itching, adults:when practical, clean the affected area with mild soap and warm water and rinse thoroughlygently 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 childre...

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Hydrocortisone 1%

Purpose

OTC - PURPOSE SECTION

Anti-Itch 

Uses

INDICATIONS & USAGE SECTION

■ temporarily relieves itching associated with minor skin irritations, inflammation, and rashes due to:

■ eczema ■ psoriasis ■ poison ivy, oak, sumac ■ insect bites ■ detergents ■ jewelry ■ cosmetics

■ soaps ■ seborrheic dermatitis

■ temporarily relieves external anal and genital itching

■ other uses of this product should only be under the advice and supervision of a doctor

Warnings 

WARNINGS SECTION

For external use only 

Do not use 

OTC - DO NOT USE SECTION

■ 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

■ 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

■ 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

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 time daily
  • children under 2 years of age: ask a doctor

for external anal itching,

  • adults:when practical, clean the affected area with mild soap and warm water and rinse thoroughlygently 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

Other information 

OTHER SAFETY INFORMATION

  • Store at a controlled room temperature 20-25°C ( 68-77°F)
  • before using any medication read all label direction, keep carton it contains important information 

Inactive ingredient 

INACTIVE INGREDIENT SECTION

Petrolatum 

Principal Display Panel 

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CVS              NDC 51316-165-28    

Maximum strength

Cortisone Ointment 

Hydrocortisone 1%

NET WT 1.0 OZ  (28g)

503200-CVSHealth-Max-Strength-Cortisone-Ointment-1-oz-Carton503200-CVSHealth-Max-Strength-Cortisone-Ointment-1-oz-Carton

203200-CVS -Tube _Hydrocortisone Ointment203200-CVS -Tube _Hydrocortisone Ointment

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
203105hydrocortisone 1 % Topical OintmentPSN2
203105hydrocortisone 0.01 MG/MG Topical OintmentSCD2
203105hydrocortisone 1 % Topical OintmentSY2

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51316-165-28CVS Health Maximum Strength Hydrocortisone1 in 1 CARTONOINTMENT12
51316-165-28CVS Health Maximum Strength Hydrocortisone28 g in 1 TUBEOINTMENT282

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51316-165CVS HEALTH MAXIMUM STRENGTH HYDROCORTISONE (HYDROCORTISONE OINTMENT) OINTMENT [CVS HEALTH]2Current NDC, 2 package rows20240805_ee9ed7ca-1642-4cf6-ae4b-d1c11b37eaf3.zip

Products#

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

DailyMed product names page 1 of 1 · 4 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
51316-16551316-165-28

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
NameUNIIKind
HYDROCORTISONEWI4X0X7BPJACTIB
PETROLATUM4T6H12BN9UIACT

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
CVS Health Maximum Strength HydrocortisoneHYDROCORTISONE OINTMENTCVS Healthee9ed7ca-1642-4cf6-ae4b-d1c11b37eaf32024-08-02WarningsExact identifier
ndc (package): 51316-165-28
ndc (product): 51316-165
ndc11 (package): 51316016528
spl id: 6b751987-9fe6-4417-aca9-067a147cd93f
spl set id: ee9ed7ca-1642-4cf6-ae4b-d1c11b37eaf3

Reported adverse events (FAERS/openFDA)#

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