NDC 54111-123 Rodan And Fields Soothe

Allantoin, Dimethicone

NDC Product Code 54111-123

NDC 54111-123-50

Package Description: 50 mL in 1 TUBE

NDC Product Information

Rodan And Fields Soothe with NDC 54111-123 is a a human over the counter drug product labeled by Bentley Laboratories, Llc. The generic name of Rodan And Fields Soothe is allantoin, dimethicone. The product's dosage form is cream and is administered via topical form.

Labeler Name: Bentley Laboratories, Llc

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.

Rodan And Fields Soothe 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.

  • ALLANTOIN .25 g/50mL
  • DIMETHICONE 1.45 g/50mL

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.

  • WATER (UNII: 059QF0KO0R)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • ISODODECANE (UNII: A8289P68Y2)
  • SODIUM ACRYLATE (UNII: 7C98FKB43H)
  • HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
  • MICA (UNII: V8A1AW0880)
  • SOYBEAN GERM (UNII: JBW2VHD14M)
  • PEG-40 STEARATE (UNII: ECU18C66Q7)
  • LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
  • CAPRYLYL GLYCOL (UNII: 00YIU5438U)
  • XANTHAN GUM (UNII: TTV12P4NEE)
  • CHLORPHENESIN (UNII: I670DAL4SZ)
  • 1,2-HEXANEDIOL (UNII: TR046Y3K1G)
  • POLYGLYCERYL-10 STEARATE (UNII: 90TF85HH91)
  • SUNFLOWER OIL (UNII: 3W1JG795YI)
  • LINOLEIC ACID (UNII: 9KJL21T0QJ)
  • CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E)
  • LEVOMENOL (UNII: 24WE03BX2T)
  • HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)
  • PERILLA FRUTESCENS SEED OIL (UNII: 322MS57V7Z)
  • COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H)
  • ANGELICA POLYMORPHA ROOT (UNII: HZ12173363)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • HONEY (UNII: Y9H1V576FH)
  • CHAMOMILE (UNII: FGL3685T2X)
  • PELARGONIUM GRAVEOLENS FLOWER OIL (UNII: 3K0J1S7QGC)
  • LAVENDER OIL (UNII: ZBP1YXW0H8)
  • SODIUM BENZOATE (UNII: OJ245FE5EU)
  • RICE BRAN (UNII: R60QEP13IC)
  • INDIAN FRANKINCENSE (UNII: 4PW41QCO2M)
  • TRANEXAMIC ACID (UNII: 6T84R30KC1)
  • DECYL GLUCOSIDE (UNII: Z17H97EA6Y)
  • HEXYLENE GLYCOL (UNII: KEH0A3F75J)
  • TROPOLONE (UNII: 7L6DL16P1T)
  • POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
  • TOCOPHEROL (UNII: R0ZB2556P8)

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: 02-05-2010 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: 12-31-2021 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".

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Rodan And Fields Soothe Product Label Images

Rodan And Fields Soothe 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

Active Ingredients:

Allantion 0.5%Dimethicone 2.9%

Purpose:

Skin protectants

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.

Uses:

Temporarily protcts and helps relieve chapped or cracked skin. Helps protect from the drying effects of wind and cold weather.

Warnings:

For external use only. When using this product do not get into eyes. Stop use and ask doctor if condition worsens and symptoms last more than 7 days or clear up and occur again within a few days. Do not use on deep or puncture wounds, animal bites and serious burns.

Directions:

Apply a generous dime-sized amount evenly over the entire face, avoiding the eye area. Do not rinse off. Use twice daily.

Inactive Ingredients:

Water (Aqua), Glycerin, Isododecane, Sodium Acrylates Copolymer, Hydrogenated Polyisobutene, Titanium Dioxide (CI 77891), Butylene Glycol, Mica (CI 77019), Glycine Soja (Soybean) Germ Extract, PEG-40 Stearate, Phospholipids, Polysilicone-11, Caprylyl Glycol, Xanthan Gum, Chlorphenesin, 1,2-Hexanediol, Polyglyceryl-10 Stearate, Helianthus Annuus (Sunflower) Seed Oil, Linoleic Acid, Chlorhexidine Digluconate, Bisabolol, Lysolecithin, Perilla Ocymoides Seed Oil, Dimethylacrylamide/Acrylic Acid/Polystyrene Ethyl Methacrylate Copolymer, Coco-Caprylate/Caprate, Angelica Polymorpha Sinensis Root Extract, Phenoxyethanol, Honey Extract, Chamomilla Recutita (Matricaria) Flower Extract, Pelargonium Graveolens Flower Oil, Lavandula Angustifolia (Lavender) Oil, Sodium Benzoate, Oryza Sativa (Rice) Bran Extract, Boswellia Serrata Extract, Tetrapeptide-16, Tranexamic Acid, Decyl Glucoside, Oligopeptide-10, Hexylene Glycol, Tropolone, Potassium Sorbate, Tocopherol

Rodan And Fields Soothe Label

RODAN and FIELDS SOOTHE2 Sensitive Skin TreatmentManufactured for Rodan and Fields, LLCSan Francisco, CA 94105Made in USA  SOTT00   85-06-00129 Please Recyclevisit rodanandfields.comQUESTIONS OR COMMENTS1-888-995-565650mL/1.7 Fl. Oz.

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