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

PRINCIPAL DISPLAY PANEL - 60 g Tube Box
CLINICALM 
hydrocortisone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68726-123
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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
ColorWHITE (Off White) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68726-123-041 in 1 BOX06/01/201509/30/2023
1198 g in 1 TUBE; Type 0: Not a Combination Product
2NDC:68726-123-031 in 1 BOX06/01/201504/30/2024
260 g in 1 TUBE; Type 0: Not a Combination Product
3NDC:68726-123-027 g in 1 TUBE; Type 0: Not a Combination Product06/01/201501/31/2024
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph drugM01706/01/201504/30/2024
Labeler - CP Skin Health Group, Inc. (611921669)

Revised: 12/2023
 
CP Skin Health Group, Inc.