Drugplain

CliniCalm 1 g/100g

Hydrocortisone · CREAM · CP Skin Health Group, Inc.

No Recall HistoryCurrently in Shortage
Plain English

Hydrocortisone cream is a topical corticosteroid used to reduce inflammation and itching associated with various skin conditions. This over-the-counter product is applied directly to the affected skin area.

Key Facts

Brand Name
CliniCalm
Generic Name
Hydrocortisone
NDC Code (Product)
68726-504
Manufacturer
CP Skin Health Group, Inc.
Strength
1 g/100g
Dosage Form
CREAM
Route
TOPICAL
Marketing Status
Application #
M006
Drug Class
Corticosteroid [EPC]
Marketing Start
07/01/2023

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

off label use9,163 reports
drug ineffective7,258 reports
fatigue5,735 reports
condition aggravated5,322 reports
nausea4,844 reports
rash4,744 reports
diarrhoea4,331 reports
pain4,322 reports
headache4,308 reports
arthralgia4,153 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

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 & Administration

Directions 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.

Warnings

Warnings 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. Do not use for the treatment of diaper rash. Consult a physician. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

Frequently Asked Questions

What is CliniCalm used for?

Hydrocortisone cream is a topical corticosteroid used to reduce inflammation and itching associated with various skin conditions. This over-the-counter product is applied directly to the affected skin area.

Is CliniCalm a controlled substance?

CliniCalm is not classified as a controlled substance by the DEA.

What is the generic name for CliniCalm?

The generic name for CliniCalm is Hydrocortisone. There are 12 other brand versions of Hydrocortisone.

What is the NDC code for CliniCalm 1 g/100g?

The NDC (National Drug Code) for CliniCalm 1 g/100g is 68726-504, listed by CP Skin Health Group, Inc..

Product NDC

68726-504

Package NDC

68726-504-01

Other Hydrocortisone Brands

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)