NDC 14222-2430 Soothe Moisturizing Rescue Cream

Oatmeal

NDC Product Code 14222-2430

NDC 14222-2430-1

Package Description: 1 TUBE in 1 CARTON > 30 mL in 1 TUBE

NDC Product Information

Soothe Moisturizing Rescue Cream with NDC 14222-2430 is a a human over the counter drug product labeled by Rodan & Fields. The generic name of Soothe Moisturizing Rescue Cream is oatmeal. The product's dosage form is cream and is administered via topical form.

Labeler Name: Rodan & Fields

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.

Soothe Moisturizing Rescue Cream 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.

  • OATMEAL .01 g/mL

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.

  • ASCORBYL PALMITATE (UNII: QN83US2B0N)
  • BEHENIC ACID (UNII: H390488X0A)
  • SHEA BUTTER (UNII: K49155WL9Y)
  • C12-16 ALCOHOLS (UNII: S4827SZE3L)
  • CALCIUM GLUCONATE (UNII: SQE6VB453K)
  • N-HEXANOYLSPHINGOSINE (UNII: 038753E78J)
  • MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
  • CAPRYLYL GLYCOL (UNII: 00YIU5438U)
  • CERAMIDE AP (UNII: F1X8L2B00J)
  • CERAMIDE 1 (UNII: 5THT33P7X7)
  • 3-DEHYDROXY CERAMIDE 1 (UNII: CR0J8RN66K)
  • CERAMIDE NP (UNII: 4370DF050B)
  • CERAMIDE NG (UNII: C04977SRJ5)
  • CETEARETH-25 (UNII: 8FA93U5T67)
  • CETYL ALCOHOL (UNII: 936JST6JCN)
  • CHOLESTEROL (UNII: 97C5T2UQ7J)
  • CURCUMA KWANGSIENSIS ROOT (UNII: 2WSI2681TI)
  • CYNARA SCOLYMUS LEAF (UNII: B71UA545DE)
  • DECYL GLUCOSIDE (UNII: Z17H97EA6Y)
  • DIMETHICONE (UNII: 92RU3N3Y1O)
  • GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)
  • EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
  • ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
  • GLUCONOLACTONE (UNII: WQ29KQ9POT)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • SUNFLOWER OIL (UNII: 3W1JG795YI)
  • HEXYLENE GLYCOL (UNII: KEH0A3F75J)
  • HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)
  • LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
  • MALTODEXTRIN (UNII: 7CVR7L4A2D)
  • OPHIOPOGON JAPONICUS ROOT (UNII: 90PS6JV9GZ)
  • PRICKLY PEAR FRUIT (UNII: 18V8PAQ629)
  • PALMITIC ACID (UNII: 2V16EO95H1)
  • PANTHENOL (UNII: WV9CM0O67Z)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
  • POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
  • PROPANEDIOL (UNII: 5965N8W85T)
  • SODIUM BENZOATE (UNII: OJ245FE5EU)
  • TOCOPHEROL (UNII: R0ZB2556P8)
  • WATER (UNII: 059QF0KO0R)
  • XANTHAN GUM (UNII: TTV12P4NEE)
  • YEAST, UNSPECIFIED (UNII: 3NY3SM6B8U)

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: 03-09-2021 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.

Soothe Moisturizing Rescue Cream 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 Ingredient

Colloidal
Oatmeal 1 %

Purpose

Skin Protectant

Uses

Temporarily protects and helps relieve minor skin irritation and itching due to • rashes • eczema.

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.

Keep Out Of Reach Of Children.

If product is swallowed, get medical help right away.

Directions

Apply an even layer over face and neck as needed. Avoid eye area. Use AM + PM after Sensitive Skin Treatment.

Inactive Ingredients

Aqua/Eau/Water, Ascorbyl Palmitate, Behenic Acid, Butyrospermum Parkii (Shea) Butter, C12-16 Alcohols, Calcium Gluconate, Caprooyl Phytosphingosine, Caprooyl Sphingosine, Caprylic/Capric Triglyceride, Caprylyl Glycol, Ceramide AP, Ceramide EOP, Ceramide EOS, Ceramide NP, Ceramide NS, Ceteareth-25, Cetyl Alcohol, Cholesterol, Curcuma Wenyujin/Curcuma Kwangsiensis Rhizome Extract, Cynara Scolymus (Artichoke) Leaf Extract, Decyl Glucoside, Dimethicone, Dipotassium Glycyrrhizate, Disodium EDTA, Ethylhexylglycerin, Gluconolactone, Glycerin, Helianthus Annuus (Sunflower) , Seed Oil, Hexylene Glycol, Hydrogenated Lecithin, Lecithin, Maltodextrin, Ophiopogon Japonicus Root Extract, Opuntia Ficus-lndica Fruit Extract, Palmitic Acid, Panthenol, Phenoxyethanol, Polysilicone-11, Potassium Sorbate, Propanediol, Sodium Acrylates Copolymer, Sodium Benzoate, Tocopherol, Xanthan Gum, Yeast Extract.

Questions?

1-888-995-5656

* Please review the disclaimer below.