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Product NDC Code | 49967-108 | ||||||
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Drug Name | Cerave developed with dermatologists anti itch |
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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 | ||||||
Application Number | M017 | ||||||
Labeler Name | L'Oreal USA Products Inc. | ||||||
Packages |
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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, ask a doctor
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients water, cetearyl alcohol, glycerin, ceteareth-20, isopropyl myristate, cyclopentasiloxane, benzyl alcohol, isostearyl neopentanoate, cetyl palmitate, PEG-40 stearate,. potassium lactate, ceramide NP, ceramide AP, potassium sorbate,. ceramide EOP, carbomer, niacinamide, dimethicone/vinyltrimethylsiloxysilicate crosspolymer, dimethyl MEA, aloe barbadensis leaf juice, methylparaben, sodium lauroyl lactylate, sodium hyaluronate, sodium benzoate, cholesterol, avena sativa (oat) kernel extract, phenoxyethanol, citric acid, phytosphingosine, xanthan gum, maltodextrin, chrysanthemum parthenium (feverfew) extract, ethylhexylglycerin
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 temporarily relieves itching associated with minor skin irritations, inflammation, and rashes due to: eczema, soaps, detergents, cosmetics, seborrheic dermatitis, psoriasis other uses of this product should only be under the advice and supervision of a doctor
Purpose
Information about the drug product’s indications for use.Purpose Anti-itch
Spl product data elements
Usually a list of ingredients in a drug product.CeraVe Developed with Dermatologists Anti Itch Hydrocortisone HYDROCORTISONE HYDROCORTISONE WATER CETOSTEARYL ALCOHOL POLYOXYL 20 CETOSTEARYL ETHER GLYCERIN ISOPROPYL MYRISTATE CYCLOMETHICONE 5 BENZYL ALCOHOL CETYL PALMITATE ISOSTEARYL NEOPENTANOATE CITRIC ACID MONOHYDRATE POTASSIUM LACTATE POTASSIUM SORBATE DEANOL PEG-40 STEARATE METHYLPARABEN ALOE VERA LEAF NIACINAMIDE OAT SODIUM LAUROYL LACTYLATE HYALURONATE SODIUM SODIUM BENZOATE PHENOXYETHANOL TANACETUM PARTHENIUM CERAMIDE 3 CERAMIDE 6 II PHYTOSPHINGOSINE CHOLESTEROL XANTHAN GUM MALTODEXTRIN CERAMIDE 1 ETHYLHEXYLGLYCERIN
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.image of a carton
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 uses for the treatment of diaper rash. Consult a doctor.
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 swallowed, get medical help or contact a Poison Control Center right away.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Other information store at 20° to 25°C (68° to 77°F)
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions Toll-free number 1-888-768-2915 www.CeraVe.com
Stop use
Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.Stop use and ask a doctor if if condition worsens or if symptoms persist for more than 7 days, or clear up and occur again within a few days. Do not begin use of any other hydrocortisone product unless you have consulted a doctor.
When using
Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.When using this product avoid contact with the eyes
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
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