NDC 54111-154 Intensive Daily Repair Body Butter

Colloidal Oatmeal

NDC Product Code 54111-154

NDC 54111-154-50

Package Description: 1 JAR in 1 CARTON > 170 g in 1 JAR

NDC Product Information

Intensive Daily Repair Body Butter with NDC 54111-154 is a a human over the counter drug product labeled by Bentley Laboratories, Llc. The generic name of Intensive Daily Repair Body Butter is colloidal oatmeal. The product's dosage form is cream and is administered via topical form. The RxNorm Crosswalk for this NDC code indicates a single RxCUI concept is associated to this product: 2556910.

Dosage Form: Cream - An emulsion, semisolid3 dosage form, usually containing > 20% water and volatiles5 and/or < 50% hydrocarbons, waxes, or polyols as the vehicle. This dosage form is generally for external application to the skin or mucous membranes.

Product Type: Human Otc Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Intensive Daily Repair Body Butter Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.


Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
  • SHEA BUTTER (UNII: K49155WL9Y)
  • ARGAN OIL (UNII: 4V59G5UW9X)
  • GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
  • STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • .ALPHA.-GLUCAN OLIGOSACCHARIDE (UNII: S95658MI3W)
  • DIISOPROPYL ADIPATE (UNII: P7E6YFV72X)
  • GLYCERYL MONOBEHENATE (UNII: A626UU0W2A)
  • SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)
  • SQUALANE (UNII: GW89575KF9)
  • WATER (UNII: 059QF0KO0R)
  • LEVOMENOL (UNII: 24WE03BX2T)
  • OCTYLDODECYL BEHENATE (UNII: BZM9WE5P6F)
  • XYMENYNIC ACID (UNII: IA0Z48P13W)
  • CITRIC ACID ACETATE (UNII: DSO12WL7AU)
  • ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Bentley Laboratories, Llc
Labeler Code: 54111
FDA Application Number: part347 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 06-11-2021 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2022 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N - NO What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

* Please review the disclaimer below.

Intensive Daily Repair Body Butter Product Label Images

Intensive Daily Repair Body Butter Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Otc - Active Ingredient

Drug FactsActive IngredientColloidal Oatmeal 0.8%

Otc - Purpose

PurposeSkin protectant

Indications & Usage

Uses• temporarily protects and helps relieve minor skin irritation and itching due to eczema

Warnings

WarningsFor external use onlyWhen 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.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away

Dosage & Administration

Directions apply as needed.

Inactive Ingredient

Inactive Ingredients: Aloe Barbadensis Leaf Juice**, Caprylic/Capric Triglyceride**, ButyrospermumParkii (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

Other Safety Information

Other information• Store at room temperature.

Otc - Questions

Questions or comments? Call us at (888) 215-8733or visit us at www.josiemaran.com Monday to Friday 6am-6pm PST

Product Package

JOSIE MARANARGAN APOTHECARYIntensive Daily Repair Body ButterEczema Relief with Argan Oil + Colloidal OatmealNet Wt. 170g 6 oz.FULL OF NATURALLY-DERIVED AND ORGANIC INGREDIENTSDist. by Josie Maran Cosmetics, LLCHollywood, CA [email protected]

* Please review the disclaimer below.