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Product NDC Code | 0299-4127 | ||||||
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Drug Name | Cetaphil eczema flare-up cream |
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Type | Brand | ||||||
Pharm Class | Allergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Grain Proteins [EXT], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS] |
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Active Ingredients |
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Route | TOPICAL | ||||||
Dosage Form | CREAM | ||||||
RxCUI drug identifier | 1189915 | ||||||
Application Number | M016 | ||||||
Labeler Name | Galderma Laboratories, L.P. | ||||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredients......Purpose Colloidal Oatmeal 2%......Skin Protectant
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 ● apply as needed
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients WATER, ETHYLHEXYL PALMITATE, GLYCERIN, BUTYROSPERMUM PARKII (SHEA) BUTTER, CETEARYL ALCOHOL, HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL, DIMETHICONE, PENTYLENE GLYCOL, GLYCERYL STEARATE, AVENA SATIVA (OAT) KERNEL FLOUR, PEG-100 STEARATE, MICROCRYSTALLINE CELLULOSE, SODIUM PCA, ARGININE, SODIUM POLYACRYLATE STARCH, CAPRYLYL GLYCOL, CITRIC ACID, SODIUM PHYTATE, CELLULOSE GUM, OPHIOPOGON JAPONICUS ROOT EXTRACT, XANTHAN GUM, TOCOPHERYL ACETATE, MALTODEXTRIN, CERAMIDE NP
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 protects and helps relieve minor skin irritation and itching due to: ●Eczema ●Rashes
Spl product data elements
Usually a list of ingredients in a drug product.Cetaphil Eczema Flare-Up Cream colloidal oatmeal Oatmeal Oatmeal Water Ethylhexyl Palmitate Glycerin Sheanut Oil Cetostearyl Alcohol Sunflower Oil Dimethicone Pentylene Glycol Glyceryl Monostearate Peg-100 Stearate Microcrystalline Cellulose Sodium Pyrrolidone Carboxylate Arginine Caprylyl Glycol Citric Acid Monohydrate Phytate Sodium Carboxymethylcellulose Sodium, Unspecified Ophiopogon Japonicus Root Xanthan Gum .Alpha.-Tocopherol Acetate Maltodextrin Ceramide Np 052733 P56553-0 RD Eczema Flare-up Cream 8oz Tube
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.PRINCIPLE DISPLAY PANEL - 8 OZ tube NEW #1 Doctor Recommended Sensitive Skincare Brand Cetaphil ® ECZEMA RESTORADERM ® Flare - Up Relief Cream 1 Relieve, 2 Repair, 3 Protect Relieves eczema symptoms after 1 use and repairs skin's barrier Skin Protectant Colloidal Oatmeal Microbiome gentle Ad-Resyl ® Steroid free National Eczema Association logo 8 FL OZ (226 mL) P56553-0
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? 1-866-735-4137 Distributed by: Galderma Laboratories, L.P. Fort Worth, TX 76177 All trademarks are the property of their respective owners Made in Canada Cetaphil.com
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. When using this product ● do not get into eyes. Stop use and ask a doctor if ● condition worsens ● symptoms last more than 7 days or clear up and occur again within a few days. Keep out of reach of children. If 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