NDC 14222-1005 Soothe Sensitive Skin Treatment

Allantoin, Dimethicone

NDC Product Code 14222-1005

NDC 14222-1005-1

Package Description: 1 TUBE in 1 BOX > 50 mL in 1 TUBE (14222-1005-0)

NDC Product Information

Soothe Sensitive Skin Treatment with NDC 14222-1005 is a a human over the counter drug product labeled by Rodan & Fields. The generic name of Soothe Sensitive Skin Treatment is allantoin, dimethicone. The product's dosage form is lotion and is administered via topical form.

Dosage Form: Lotion - An emulsion, liquid1 dosage form. This dosage form is generally for external application to the skin.2

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.

Soothe Sensitive Skin Treatment 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.

  • WATER (UNII: 059QF0KO0R)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • ISODODECANE (UNII: A8289P68Y2)
  • RICE BRAN (UNII: R60QEP13IC)
  • CHAMOMILE (UNII: FGL3685T2X)
  • PELARGONIUM GRAVEOLENS FLOWER OIL (UNII: 3K0J1S7QGC)
  • LAVENDER OIL (UNII: ZBP1YXW0H8)
  • INDIAN FRANKINCENSE (UNII: 4PW41QCO2M)
  • OLIGOPEPTIDE-10 (UNII: Q46328TRNK)
  • TOCOPHEROL (UNII: R0ZB2556P8)
  • TROPOLONE (UNII: 7L6DL16P1T)
  • TRANEXAMIC ACID (UNII: 6T84R30KC1)
  • HONEY (UNII: Y9H1V576FH)
  • SOYBEAN GERM (UNII: JBW2VHD14M)
  • PERILLA FRUTESCENS SEED OIL (UNII: 322MS57V7Z)
  • SUNFLOWER OIL (UNII: 3W1JG795YI)
  • LEVOMENOL (UNII: 24WE03BX2T)
  • ANGELICA SINENSIS ROOT (UNII: B66F4574UG)
  • LINOLEIC ACID (UNII: 9KJL21T0QJ)
  • LINOLENIC ACID (UNII: 0RBV727H71)
  • BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
  • COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H)
  • DECYL GLUCOSIDE (UNII: Z17H97EA6Y)
  • HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)
  • PEG-40 STEARATE (UNII: ECU18C66Q7)
  • LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
  • POLYGLYCERYL-10 STEARATE (UNII: 90TF85HH91)
  • DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
  • XANTHAN GUM (UNII: TTV12P4NEE)
  • HEXYLENE GLYCOL (UNII: KEH0A3F75J)
  • STANNIC OXIDE (UNII: KM7N50LOS6)
  • 1,2-HEXANEDIOL (UNII: TR046Y3K1G)
  • CAPRYLYL GLYCOL (UNII: 00YIU5438U)
  • CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E)
  • CHLORPHENESIN (UNII: I670DAL4SZ)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
  • SODIUM BENZOATE (UNII: OJ245FE5EU)
  • .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
  • GERANIOL (UNII: L837108USY)
  • LINALOOL, (+/-)- (UNII: D81QY6I88E)
  • MICA (UNII: V8A1AW0880)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

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: Rodan & Fields
Labeler Code: 14222
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: 06-01-2017 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".

* Please review the disclaimer below.

Soothe Sensitive Skin Treatment Product Label Images

Soothe Sensitive Skin Treatment 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

Allantoin 0.5%
Dimethicone 2.9%

Purpose

Skin protectant

Uses

  • Temporarily protects 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
  • 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
  • Serious burns

Keep Out Of Reach Of Children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Apply a thin, even layer over the entire face, avoiding the eye area. Do not rinse off. Use twice daily. Apply as needed.

Inactive Ingredients

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

Other Information

  • Store between 15-30 ºC (59-86 ºF),Do not refrigerate.

* Please review the disclaimer below.