CliniCalm by Physicians Care Alliance, LLC (d/b/a PCA Skin) CliniCalm® 1%

Drug Details [pdf]

CLINICALM- hydrocortisone cream
CP Skin Health Group, Inc.

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CliniCalm® 1%

Drug Facts

Active ingredient

Hydrocortisone (1%)

Purpose

Antipruritic (anti-itch)

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.

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.

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.

Other information

Store at 15°–25°C (59°–77°F).

Inactive ingredients

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?

877.722.7546

PRINCIPAL DISPLAY PANEL - 60 g Tube Box

PCA skin®

CliniCalm® 1%

e net wt 2.1 oz/60g

CLINICALM
hydrocortisone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68726-123
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ)	HYDROCORTISONE	1 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
4-TERT-BUTYLCYCLOHEXANOL (UNII: K0H1405S9C)
ALCOHOL (UNII: 3K9958V90M)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ASIATICOSIDE (UNII: PKO39VY215)
OAT BRAN (UNII: KQX236OK4U)
LEVOMENOL (UNII: 24WE03BX2T)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
CERAMIDE NP (UNII: 4370DF050B)
CETEARYL OLIVATE (UNII: 58B69Q84JO)
GLYCERIN (UNII: PDC6A3C0OX)
SUNFLOWER OIL (UNII: 3W1JG795YI)
HONEY (UNII: Y9H1V576FH)
HYALURONIC ACID (UNII: S270N0TRQY)
HYDROXYPHENYL PROPAMIDOBENZOIC ACID (UNII: 25KRT26H77)
LINSEED OIL (UNII: 84XB4DV00W)
LYSINE HYDROCHLORIDE (UNII: JNJ23Q2COM)
OLIVE OIL (UNII: 6UYK2W1W1E)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
SORBIC ACID (UNII: X045WJ989B)
SORBITAN OLIVATE (UNII: MDL271E3GR)
SOY SPHINGOLIPIDS (UNII: P491F5HP1U)
SQUALANE (UNII: GW89575KF9)
TOCOPHEROL (UNII: R0ZB2556P8)
TRISODIUM ETHYLENEDIAMINE DISUCCINATE (UNII: YA22H34H9Q)
TROPOLONE (UNII: 7L6DL16P1T)
WATER (UNII: 059QF0KO0R)
XANTHAN GUM (UNII: TTV12P4NEE)

Product Characteristics
Color	WHITE (Off White)	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC: 68726-123-04	1 in 1 BOX	06/01/2015	09/30/2023
1		198 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 68726-123-03	1 in 1 BOX	06/01/2015	04/30/2024
2		60 g in 1 TUBE; Type 0: Not a Combination Product
3	NDC: 68726-123-02	7 g in 1 TUBE; Type 0: Not a Combination Product	06/01/2015	01/31/2024

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph drug	M017	06/01/2015	04/30/2024

Labeler - CP Skin Health Group, Inc. (611921669)

Revised: 12/2023

Document Id: 32f417ac-7367-42b1-8adf-7a7dd43ce2ac

Set id: cf1d9de5-06c2-415a-8bd0-211fa3dab57d

Version: 3

Effective Time: 20231222

Trademark Results [CliniCalm]

Mark Image Registration \| Serial	Company Trademark Application Date
CLINICALM 86590950 not registered Dead/Abandoned	PHYSICIANS CARE ALLIANCE, LLC 2015-04-08
CLINICALM 86590938 4929004 Live/Registered	PHYSICIANS CARE ALLIANCE, LLC 2015-04-08