CliniCalm

Manufacturer
CP Skin Health Group, Inc.
Effective date
2023-12-22
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 21:16:40

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%

e net wt 2.1 oz/60g

PRINCIPAL DISPLAY PANEL - 60 g Tube Box
PRINCIPAL DISPLAY PANEL - 60 g Tube Box

Products#

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

DailyMed product names page 1 of 1 · 36 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68726-12368726-123-04, 68726-123-03, 68726-123-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 35 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
32f417ac-7367-42b1-8adf-7a7dd43ce2accf1d9de5-06c2-415a-8bd0-211fa3dab57d2023-12-22WarningsExact identifier
spl id: 32f417ac-7367-42b1-8adf-7a7dd43ce2ac
spl set id: cf1d9de5-06c2-415a-8bd0-211fa3dab57d

Reported adverse events (FAERS/openFDA)#

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