CliniCalm ® 1% Hydrocortisone Cream

Manufacturer
CP Skin Health Group, Inc.
Effective date
2024-12-03
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 00:40:28

Label at a glance#

ProductCliniCalm
Active ingredientHYDROCORTISONE
Label structure10 sections

Indications and uses

For the temporary relief of itching and discomfort associated with minor skin irritations and rashes due to eczema, psoriasis, insect bites, poison ivy, poison oak, or poison sumac, soaps, detergents, cosmetics, jewelry, seborrheic dermatitis, etc.

Dosage and administration

Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily. Children under 2 years of age: Do not use, consult a physician.

Storage and handling

Store at 15°–25°C (59°–77°F).

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Hydrocortisone (1%)

Purpose

OTC - PURPOSE SECTION

Antipruritic (anti-itch)

Uses

INDICATIONS & USAGE SECTION

For the temporary relief of itching and discomfort associated with minor skin irritations and rashes due to eczema, psoriasis, insect bites, poison ivy, poison oak, or poison sumac, soaps, detergents, cosmetics, jewelry, seborrheic dermatitis, etc.

Warnings

WARNINGS SECTION

For external use only

Avoid contact with the eyes.

If condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, stop use of this product and do not begin use of any other hydrocortisone product unless you have consulted a physician.

OTC - DO NOT USE SECTION

Do not use for the treatment of diaper rash. Consult a physician.

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If product is 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 times daily. Children under 2 years of age: Do not use, consult a physician.

Other information

STORAGE AND HANDLING SECTION

Store at 15°–25°C (59°–77°F).

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water/Aqua/Eau, Glycerin, Caprylic/Capric Triglyceride, Alcohol Denat., Cetearyl Olivate, Squalane, Olea Europaea (Olive) Fruit Oil, Sorbitan Olivate, Caprylyl Glycol, Phenoxyethanol, Pentylene Glycol, Linum Usitatissimum (Linseed) Seed Oil, Xanthan Gum, 4-t-Butylcyclohexanol, 1,2-Hexanediol, Honey/Mel/Miel, Carbomer, Phospholipids, Asiaticoside, Beta-Glucan, Bisabolol, Lysine HCl, Sodium Hydroxide, Aloe Barbadensis Leaf Juice Powder, Ceramide NP, Sorbic Acid, Trisodium Ethylenediamine Disuccinate, Helianthus Annuus (Sunflower) Seed Oil, Butylene Glycol, Hyaluronic Acid, Sphingolipids, Tocopherol, Tropolone, Hydroxyphenyl Propamidobenzoic Acid.

Questions or comments?

OTC - QUESTIONS SECTION

877.722.7546

PRINCIPAL DISPLAY PANEL - 60 g Tube Box

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PCA skin ®

CliniCalm ®1%

2.1 oz/60g

CliniCalm Unit CartonCliniCalm Unit Carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
106258hydrocortisone 1 % Topical CreamPSN6
106258hydrocortisone 10 MG/ML Topical CreamSCD6
106258hydrocortisone 1 % (as hydrocortisone acetate 1.2 % ) Topical CreamSY6
106258hydrocortisone 1 % Topical CreamSY6
106258hydrocortisone 1 GM per 100 GM Topical CreamSY6

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
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
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
68726-504-01CliniCalm7 g in 1 TUBECREAM76
68726-504-02CliniCalm1 in 1 CARTONCREAM16
68726-504-02CliniCalm60 g in 1 TUBECREAM606

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68726-504CLINICALM (HYDROCORTISONE) CREAM [CP SKIN HEALTH GROUP, INC.]6Current NDC, 3 package rows20241206_febcf7e8-668c-a5c9-e053-6394a90aec39.zip

Products#

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

DailyMed product names page 1 of 1 · 38 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68726-50468726-504-02, 68726-504-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 37 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
CliniCalmHYDROCORTISONECP Skin Health Group, Inc.febcf7e8-668c-a5c9-e053-6394a90aec392024-12-03WarningsExact identifier
ndc (package): 68726-504-01
ndc (package): 68726-504-02
ndc (product): 68726-504
ndc11 (package): 68726050402
ndc11 (package): 68726050401
spl id: 2865dbce-02f6-ebe7-e063-6294a90ab3cb
spl set id: febcf7e8-668c-a5c9-e053-6394a90aec39

Reported adverse events (FAERS/openFDA)#

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