Label: CLINICALM- hydrocortisone cream
- NDC Code(s): 62282-504-01, 62282-504-02
- Packager: Northwest Cosmetic Laboratories LLC, DBA Elevation Labs, Idaho
- 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 26, 2023
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient
- Purpose
- Uses
- Warnings
- Directions
- Other information
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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.
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- PRINCIPAL DISPLAY PANEL - 60 g Tube Box
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INGREDIENTS AND APPEARANCE
CLINICALM
hydrocortisone creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:62282-504 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE 1 g in 100 g Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:62282-504-02 1 in 1 CARTON 07/01/2023 1 60 g in 1 TUBE; Type 0: Not a Combination Product 2 NDC:62282-504-01 7 g in 1 TUBE; Type 0: Not a Combination Product 07/01/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 07/01/2023 Labeler - Northwest Cosmetic Laboratories LLC, DBA Elevation Labs, Idaho (929572014)