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| Product NDC Code | 68726-504 | ||||||
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| Drug Name | Clinicalm |
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| Type | Brand | ||||||
| Pharm Class | Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC] |
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| Active Ingredients |
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| Route | TOPICAL | ||||||
| Dosage Form | CREAM | ||||||
| RxCUI drug identifier | 106258, 2533907 |
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| Application Number | part348 | ||||||
| Labeler Name | CP Skin Health Group, Inc. | ||||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient Hydrocortisone (1%)
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.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.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.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.
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.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.
Purpose
Information about the drug product’s indications for use.Purpose Antipruritic (anti-itch)
Spl product data elements
Usually a list of ingredients in a drug product.CliniCalm Hydrocortisone HYALURONATE SODIUM LECITHIN, SOYBEAN 1,2-HEXANEDIOL 4-TERT-BUTYLCYCLOHEXANOL ALCOHOL ALOE VERA LEAF ASIATICOSIDE OATMEAL LEVOMENOL BUTYLENE GLYCOL MEDIUM-CHAIN TRIGLYCERIDES CAPRYLYL GLYCOL CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE CERAMIDE NP CETEARYL OLIVATE GLYCERIN SUNFLOWER OIL HONEY HYALURONIC ACID HYDROXYPHENYL PROPAMIDOBENZOIC ACID LINSEED OIL LYSINE HYDROCHLORIDE OLIVE OIL PENTYLENE GLYCOL PHENOXYETHANOL SODIUM HYDROXIDE SORBIC ACID SORBITAN OLIVATE SOY SPHINGOLIPIDS SQUALANE TOCOPHEROL TRISODIUM ETHYLENEDIAMINE DISUCCINATE TROPOLONE WATER XANTHAN GUM HYDROCORTISONE HYDROCORTISONE YEAST .BETA.-D-GLUCAN
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.PRINCIPAL DISPLAY PANEL - 60 g Tube Box PCA skin ® CliniCalm ®1% 2.1 oz/60g CliniCalm Unit Carton
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.Drug Facts
Do not use
Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.Do not use for the treatment of diaper rash. Consult a physician.
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions or comments? 877.722.7546
Pregnancy or breast feeding
Pregnancy or Breast feedingIf pregnant or breast-feeding, ask a health professional before use.
Storage and handling
Information about safe storage and handling of the drug product.Other information Store at 15°–25°C (59°–77°F).
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.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.
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API