CVS Health Itch Relief Cream

Manufacturer
Trifecta Pharmaceuticals USA LLC
Effective date
2024-12-20
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:47:46

Label at a glance#

ProductItch Relief
Active ingredientHYDROCORTISONE
Label structure13 sections

Indications and uses

For temporary relief of itching associated with minor skin irritataions, inflammation and rashes due to Eczema Insect bites poison ivy poison oak poison sumac soaps detergents cosmetics jewelry seborrheic dermatitis psoriasis sunburn temporarily relieves external anal and genital itching. Other uses of this product should be only under the advice and supervision of a doctor

Dosage and administration

For itching or skin irritations, inflammation, and rashes. Adults and children 2 years and older Apply to affected area not more than 3 to 4 times daily. Children under 2 years of age ask a doctor. For External and Anal 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...

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Hydrocortisone 1%

Purpose

OTC - PURPOSE SECTION

Anti-itch

Keep out of Reach of Children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If Swallowed, get medical help or contact a Poison Control Center right away.

Uses

INDICATIONS & USAGE SECTION

For temporary relief of itching associated with minor skin irritataions, inflammation and rashes due to

  • Eczema
  • Insect bites
  • poison ivy
  • poison oak
  • poison sumac
  • soaps
  • detergents
  • cosmetics
  • jewelry
  • seborrheic dermatitis
  • psoriasis
  • sunburn
  • temporarily relieves external anal and genital itching.

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

Warnings

WARNINGS SECTION

For External Use Only

Do not use

  • In the genital area if you have a vaginal discharge.

When using this Product

OTC - WHEN USING SECTION

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

Stop Using this product and ask a doctor if

OTC - STOP USE SECTION

  • Conditions worsen
  • 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.

Directions

DOSAGE & ADMINISTRATION SECTION

For itching or skin irritations, inflammation, and rashes.

Adults and children 2 years and older

  • Apply to affected area not more than 3 to 4 times daily.

Children under 2 years of age

  • ask a doctor.

For External and Anal 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

Other Information

SPL UNCLASSIFIED SECTION

Store at controlled room temperature 20°-25°C (68°-77°F)

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Aloe Barbadensis leaf juice, cetyl alcohol, Dimethicone, EDTA, Ethylparaben, Ginger Oil, Glycerin, Glyceryl stearate, Maltodextrin, Methyl gluceth-20, Methylparaben, Methylpentadecane, petrolatum, 2- Phenoxyethyl alcohol, Polysorbate 80, Propylene glycol, purified water, Stearic acid, Trisodium citrate dihydrate, Vitamin E.

Questions

OTC - QUESTIONS SECTION

Call 1-800- SHOP CVS

Other Information

SPL UNCLASSIFIED SECTION

This product is not manufactured or distributed by Chattem Inc. distributor of Cortizone -10®

Distributed By:

CVS Pharmacy, Inc.

One CVS Drive,

Woonsocket, RI. 02895

Product of China V-36756

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CVS 340113 Hydrocortisone creamCVS 340113 Hydrocortisone cream

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
106258hydrocortisone 1 % Topical CreamPSN3
106258hydrocortisone 10 MG/ML Topical CreamSCD3
106258hydrocortisone 1 % (as hydrocortisone acetate 1.2 % ) Topical CreamSY3
106258hydrocortisone 1 % Topical CreamSY3
106258hydrocortisone 1 GM per 100 GM Topical CreamSY3

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
777d68c6-a5ab-e06c-d314-677b0b9af0c8Product name220240508
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
69396-057-01Itch Relief1 in 1 BOXCREAM13
69396-057-01Itch Relief28 g in 1 TUBECREAM283

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69396-057ITCH RELIEF (HYDROCORTISONE 1%) CREAM [TRIFECTA PHARMACEUTICALS USA LLC]3Current NDC, Legacy NDC, 2 package rows20241222_af5daf6c-bcad-8ebf-e053-2a95a90af1b0.zip

Products#

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

DailyMed product names page 1 of 1 · 23 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69396-05769396-057-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 21 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
Itch ReliefHYDROCORTISONE 1%Trifecta Pharmaceuticals USA LLCaf5daf6c-bcad-8ebf-e053-2a95a90af1b02024-12-20WarningsExact identifier
ndc (package): 69396-057-01
ndc (product): 69396-057
ndc11 (package): 69396005701
spl id: 29b36988-b625-40f2-e063-6294a90a39b8
spl set id: af5daf6c-bcad-8ebf-e053-2a95a90af1b0

Reported adverse events (FAERS/openFDA)#

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