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| Product NDC Code | 54111-154 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | Intensive daily repair body butter |
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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 | 2556910 | ||||||
| Application Number | M020 | ||||||
| Labeler Name | Bentley Laboratories, LLC | ||||||
| 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.Drug Facts Active Ingredient Colloidal Oatmeal 0.8%
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: Aloe Barbadensis Leaf Juice**, Caprylic/Capric Triglyceride**, Butyrospermum Parkii (Shea) Butter**, Argania Spinosa Kernel Oil*, Glyceryl Stearate**, Stearyl Alcohol**, Glycerin**, Alpha-Glucan Oligosaccharide**, Diisopropyl Adipate, Glyceryl Behenate**, Sodium Stearoyl Glutamate**, Squalane**, Water/Aqua/Eau**, Bisabolol**, Octyldodecyl PCA**, Xymenynic Acid, Citric Acid**, Ethylhexylglycerin, Phenoxyethanol. *ORGANIC **NATURALLY-DERIVED
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
Purpose
Information about the drug product’s indications for use.Purpose Skin protectant
Spl product data elements
Usually a list of ingredients in a drug product.Intensive Daily Repair Body Butter Colloidal Oatmeal OATMEAL OATMEAL ALOE VERA LEAF MEDIUM-CHAIN TRIGLYCERIDES SHEA BUTTER ARGAN OIL GLYCERYL MONOSTEARATE STEARYL ALCOHOL GLYCERIN .ALPHA.-GLUCAN OLIGOSACCHARIDE DIISOPROPYL ADIPATE GLYCERYL MONOBEHENATE SODIUM STEAROYL GLUTAMATE SQUALANE WATER LEVOMENOL OCTYLDODECYL BEHENATE XYMENYNIC ACID CITRIC ACID ACETATE ETHYLHEXYLGLYCERIN PHENOXYETHANOL
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.Product Package JOSIE MARAN ARGAN APOTHECARY Intensive Daily Repair Body Butter Eczema Relief with Argan Oil + Colloidal Oatmeal Net Wt. 170g 6 oz. FULL OF NATURALLY-DERIVED AND ORGANIC INGREDIENTS Dist. by Josie Maran Cosmetics, LLC Hollywood, CA 90038 josiemaran.com @josiemaran 170g Jar 65g Jar res 154 Jar 154 Crtn 154-52 56g Jar 154-52 56g Ctn
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 room temperature.
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? Call us at (888) 215-8733 or visit us at www.josiemaran.com Monday to Friday 6am-6pm PST
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.
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