CLINICALM- hydrocortisone cream 
Northwest Cosmetic Laboratories LLC, DBA Elevation Labs, Idaho

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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CliniCalm ®1% Hydrocortisone Cream

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%

2.1 oz/60g

CliniCalm Unit Carton

CLINICALM 
hydrocortisone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62282-504
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
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
4-TERT-BUTYLCYCLOHEXANOL (UNII: K0H1405S9C)  
ALCOHOL (UNII: 3K9958V90M)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
ASIATICOSIDE (UNII: PKO39VY215)  
OATMEAL (UNII: 8PI54V663Y)  
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)  
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)  
YEAST .BETA.-D-GLUCAN (UNII: 44FQ49X6UN)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:62282-504-021 in 1 CARTON07/01/2023
160 g in 1 TUBE; Type 0: Not a Combination Product
2NDC:62282-504-017 g in 1 TUBE; Type 0: Not a Combination Product07/01/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34807/01/2023
Labeler - Northwest Cosmetic Laboratories LLC, DBA Elevation Labs, Idaho (929572014)

Revised: 6/2023
Document Id: ff0ee7ef-00a8-1dae-e053-6294a90a059e
Set id: ff0e811b-a882-1172-e053-6394a90a01d9
Version: 1
Effective Time: 20230626
 
Northwest Cosmetic Laboratories LLC, DBA Elevation Labs, Idaho