Soothe Sensitive Skin Treatment
Allantoin, Dimethicone
Rodan & Fields
Human Otc Drug
NDC 14222-2420Soothe Sensitive Skin Treatment also known as Allantoin, Dimethicone is a human otc drug labeled by 'Rodan & Fields'. National Drug Code (NDC) number for Soothe Sensitive Skin Treatment is 14222-2420. This drug is available in dosage form of Lotion. The names of the active, medicinal ingredients in Soothe Sensitive Skin Treatment drug includes Allantoin - .5 g/100mL Dimethicone - 2 g/100mL . The currest status of Soothe Sensitive Skin Treatment drug is Active.
Drug Information:
| Drug NDC: | 14222-2420 |
| The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC. |
| Proprietary Name: | Soothe Sensitive Skin Treatment |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Product Type: | Human Otc Drug |
| Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing. |
| Non Proprietary Name: | Allantoin, Dimethicone |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Rodan & Fields |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Lotion |
| The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources. |
| Status: | Active |
| FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved. |
| Substance Name: | ALLANTOIN - .5 g/100mL
DIMETHICONE - 2 g/100mL
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | TOPICAL
|
| The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
Marketing Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Marketing Category: | OTC MONOGRAPH FINAL |
| Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (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. |
| Marketing Start Date: | 09 Mar, 2021 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 06 May, 2026 |
| This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached. |
| Application Number: | part347 |
| 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. |
| Listing Expiration Date: | 31 Dec, 2023 |
| This is the date when the listing record will expire if not updated or certified by the firm. |
OpenFDA Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Manufacturer Name: | Rodan & Fields
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| Original Packager: | Yes
|
| Whether or not the drug has been repackaged for distribution. |
| UPC: | 0884164014208
|
| UPC stands for Universal Product Code. |
| NUI: | N0000010282
|
| Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT). |
| UNII: | 344S277G0Z
92RU3N3Y1O
|
| Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information. |
| Pharmacologic Class PE: | Skin Barrier Activity [PE]
|
| Physiologic effect or pharmacodynamic effect—tissue, organ, or organ system level functional activity—of the drug’s established pharmacologic class. Takes the form of the effect, followed by `[PE]` (such as `Increased Diuresis [PE]` or `Decreased Cytokine Activity [PE]`. |
| Pharmacologic Class: | Skin Barrier Activity [PE]
|
| These are the reported pharmacological class categories corresponding to the SubstanceNames listed above. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 14222-2420-1 | 1 BOTTLE in 1 CARTON (14222-2420-1) / 50 mL in 1 BOTTLE | 09 Mar, 2021 | N/A | No |
| 14222-2420-2 | 1 TUBE in 1 CARTON (14222-2420-2) / 10 mL in 1 TUBE | 01 Jun, 2021 | N/A | No |
| 14222-2420-3 | 2 mL in 1 PACKET (14222-2420-3) | 12 Apr, 2022 | N/A | No |
| Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together. |
Purpose:
Purpose skin protectant
Product Elements:
Soothe sensitive skin treatment allantoin, dimethicone allantoin allantoin dimethicone dimethicone cherimoya ascorbic acid benzoic acid indian frankincense butylene glycol caprylyl glycol chlorphenesin citric acid monohydrate coco-caprylate/caprate decyl glucoside dehydroacetic acid glycyrrhizinate dipotassium disodium lauriminodipropionate tocopheryl phosphates glycerin enoxolone sunflower oil hexylene glycol honey hydrogenated polybutene (1300 mw) isododecane linoleic acid linolenic acid holy basil leaf oleic acid oligopeptide-10 rice bran palmitic acid panthenol peg-40 stearate phenoxyethanol phenyl trimethicone phenylpropanol phoenix dactylifera seed lecithin, soybean polyglyceryl-10 stearate dimethicone/vinyl dimethicone crosspolymer (soft particle) propanediol sodium benzoate sodium citrate, unspecified form sodium dehydroacetate stearic acid magnesium potassium aluminosilicate fluoride stannic oxide titanium dioxide tocopherol water xanthan gum
Indications and Usage:
Uses temporarily protects and helps relieve chapped or cracked skin. helps protect from the drying effects of wind and cold weather.
Warnings:
Warnings for external use only. when using this product do not get in 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.
Do Not Use:
Warnings for external use only. when using this product do not get in 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.
When Using:
When using this product do not get in eyes.
Dosage and Administration:
Directions after cleansing, apply evenly to face until it blends into skin. avoid eye area. do not rinse. use am + pm. reapply as needed.
Stop Use:
Stop use and ask doctor if condition worsens. symptoms last more than 7 days or clear up and occur again within a few days.
Package Label Principal Display Panel:
Principal display panel â 50 ml carton label rodan+fields soothe sensitive skin treatment 2 50 ml / 1.7 fl. oz u.s. principal display panel â 50 ml carton label
Principal display panel â 50 ml bottle label rodan+fields soothe sensitive skin treatment skin protectant lotion 2 principal display panel â 50 ml bottle label
Further Questions:
Questions? 1-888-995-5656