Label: CLINICALM- hydrocortisone cream

  • NDC Code(s): 68726-504-01, 68726-504-02
  • Packager: CP Skin Health Group, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

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.

Drug Label Information

Updated June 22, 2023

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  • SPL UNCLASSIFIED SECTION

    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

  • INGREDIENTS AND APPEARANCE
    CLINICALM 
    hydrocortisone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68726-504
    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:68726-504-021 in 1 CARTON07/01/2023
    160 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:68726-504-017 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 - CP Skin Health Group, Inc. (611921669)
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