ElixirCortiRelief

Manufacturer
ELIXIR HEALTHCARE USA, LLC.
Effective date
2025-12-02
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:29:23

Label at a glance#

ProductElixirCortiRelief
Active ingredientHYDROCORTISONE
Label structure13 sections

Indications and uses

For temporary relief of minor skin irritations, itching and rashes due to eczema, insect bites, poison ivy, poison oak, poison sumac, soaps, detergents, cosmetics, jewellery, for external genital, feminine and anal itching

Dosage and administration

Adults and children over 2 years of age • Apply evenly to affected area no more than 3 to 4 times daily Children under 2 years of age. Do not use. Consult a doctor. • Adults. When practical, Clean the affected area with mild soap and warm water and rinse thoroughly. Gently dry, patting or blotting with bathroom tissue or soft cloth before applying. Apply externally to the area upto 6 times daily or after each bowe...

Label contents#

Full prescribing information#

Active Ingredient (in each gram)

OTC - ACTIVE INGREDIENT SECTION

Hydrocortisone Acetate USP 1% w/w

Purpose

OTC - PURPOSE SECTION

Anti-Itch Cream

Uses

INDICATIONS & USAGE SECTION

For temporary relief of minor skin irritations, itching and rashes due to eczema, insect bites, poison ivy, poison oak, poison sumac, soaps, detergents, cosmetics, jewellery, for external genital, feminine and anal itching

Warnings

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

• In the eyes
• For diaper rash
If you have vaginal discharge, more then recommended dosage.

Ask a doctor before use in case of

OTC - ASK DOCTOR SECTION

• you are pregnant or breast-feeding

Stop use and ask a doctor if

OTC - STOP USE SECTION

• the condition worsens or if symptoms persist for more than 7 days or clear up and occur again within a few days

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.

Directions

DOSAGE & ADMINISTRATION SECTION

Adults and children over 2 years of age
• Apply evenly to affected area no more than 3 to 4 times daily
Children under 2 years of age.Do not use. Consult a doctor.
• Adults.When practical, Clean the affected area with mild soap and warm water and rinse thoroughly. Gently dry, patting or blotting with bathroom tissue or soft cloth before applying. Apply externally to the area upto 6 times daily or after each bowel movement. After application, discard pad. Do not flush in toilet.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Cetomacrogol-1000, Cetostearyl Alcohol, Chlorocresol, Edetate Disodium, Liquid Paraffin, Propylene Glycol, Purified Water, Sodium Metabisulphite, White Soft Paraffin.

Other information

SPL UNCLASSIFIED SECTION

Store at 20°-25°C (68°-77°F)
avoid excessive heat and humidity

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Reorder No. xxxx

Elixir

Hydrocortisone Cream 1%

Anti-Itch Cream

Net Wt. 1 OZ. (28.3G)

tube-boxtube-box

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Elixir

Hydrocortisone Cream 1%

Anti-Itch Cream

Maximum Strength

16 oz (454 g)

24 Jars

itching and rashes

Relief of minor skin irritation

NDC: 84546-0005-01

Net Wt. 16 OZ. 9454G)

Reorder No:

MPR-XXXXX

image descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1043690hydrocortisone acetate 1 % Topical CreamPSN1
1043690hydrocortisone acetate 10 MG/ML Topical CreamSCD1
1043690hydrocortisone acetate 1 % Topical CreamSY1

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
84546-0005-1ElixirCortiRelief1 in 1 CARTONCREAM11
84546-0005-1ElixirCortiRelief28.3 g in 1 TUBECREAM28.31
84546-0005-2ElixirCortiRelief24 in 1 CASECREAM241
84546-0005-2ElixirCortiRelief454 g in 1 JARCREAM4541

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
84546-000584546-0005-1, 84546-0005-2

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
ElixirCortiReliefHYDROCORTISONEELIXIR HEALTHCARE USA, LLC.a6ca66f3-9759-4c98-a758-45700bc083522025-12-02WarningsExact identifier
ndc (package): 84546-0005-1
ndc (package): 84546-0005-2
ndc (product): 84546-0005
ndc11 (package): 84546000501
ndc11 (package): 84546000502
spl id: 44f6ba8a-09f3-7425-e063-6294a90a740c
spl set id: a6ca66f3-9759-4c98-a758-45700bc08352

Reported adverse events (FAERS/openFDA)#

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