FDA.reportPublic FDA data

ADVANCED ANTI-ITCH THERAPY

Manufacturer
CVS Pharmacy, Inc.
Effective date
2016-06-14
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:46:17

Label at a glance#

ProductADVANCED ANTI-ITCH THERAPY
Active ingredientHYDROCORTISONE ACETATE
Label structure12 sections

Dosage and administration

adults and children 2 years of age and older: ■wash affected area not more than 3 to 4 times daily children under 2 years of age: ■do not use. Ask a doctor.

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Hydrocortisone 1%

Purpose

OTC - PURPOSE SECTION

Anti-itch

Use

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

For external use only

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

  • Keep out of the reach of children.
  • If swallowed, get medical help or contact a Poison Control Center immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

adults and children 2 years of age and older:
■wash affected area not more than 3 to 4 times daily children under 2 years of age:
■do not use. Ask a doctor.

When using this product

OTC - WHEN USING SECTION

When using this product ■ avoid contact with the eyes.

Stop use and ask a doctor if

OTC - ASK DOCTOR 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

Do not use

OTC - DO NOT USE SECTION

Do not use ■ for external genital itching if you have a vaginal discharge. Ask a doctor

INACTIVE INGREDIENT SECTION

Sodium Palmate, Sodium Cocoate, Water, Palmitic Acid, Glycerin, Sodium Chloride, Hydrogenated Jojoba Oil, Titanium Dioxide (CI 77891), Tetrasodium EDTA, Tetrasodium Etidronate

Questions?

OTC - QUESTIONS SECTION

www.CVS.com

1-800-SHOP CVS

Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BoxBox

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
69842-345-442023-01-30C16284748780-1f386c64a-1655-0266-e053-dadaa90a7c1aADVANCED ANTI-ITCH THERAPY

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69842-345-44ADVANCED ANTI-ITCH THERAPY119 g in 1 BOXSOAP1191

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69842-345ADVANCED ANTI-ITCH THERAPY (HYDROCORTISONE) SOAP [CVS PHARMACY, INC.]1Legacy NDC, 1 package rows20160615_3543a40d-055a-158b-e054-00144ff8d46c.zip

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69842-34569842-345-44

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
TITANIUM DIOXIDE15FIX9V2JPIACT
SODIUM PALMATES0A6004K3ZIACT
SODIUM COCOATER1TQH25F4IIACT
PALMITIC ACID2V16EO95H1IACT
GLYCERINPDC6A3C0OXIACT
HYDROCORTISONE ACETATE3X7931PO74ACTIB
SODIUM CHLORIDE451W47IQ8XIACT
ETIDRONATE TETRASODIUMCZZ9T1T1X4IACT
EDETATE SODIUMMP1J8420LUIACT
HYDROGENATED JOJOBA OIL7F674YQ5SOIACT
WATER059QF0KO0RIACT

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
3543a40d-055b-158b-e054-00144ff8d46c3543a40d-055a-158b-e054-00144ff8d46c2016-06-14WarningsExact identifier
spl id: 3543a40d-055b-158b-e054-00144ff8d46c
spl set id: 3543a40d-055a-158b-e054-00144ff8d46c

Reported adverse events (FAERS/openFDA)#

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