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Intensive daily repair body butter - Medication Information

Product NDC Code 54111-162
Drug Name

Intensive daily repair body butter

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]
Active Ingredients
Oatmeal 8 mg/ml
Route TOPICAL
Dosage Form CREAM
RxCUI drug identifier 2556910
Application Number M016
Labeler Name Bentley Laboratories, LLC
Packages
Package NDC Code Description
54111-162-50 10 ml in 1 packet (54111-162-50)
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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.
HOW TO USE: Apply twice daily or as needed to soothe irritation and itching due to eczema.

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 10mL | 0.34 fl. oz. Dist. by Josie Maran Cosmetics, LLC Hollywood, CA 90038 josiemaran.com | @josiemaran res 162-50 10mL Pakt

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

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