NDC 14222-2110 Unblemish Gentle Exfoliating Acne Wash

Salicylic Acid

NDC Product Code 14222-2110

NDC Code: 14222-2110

Proprietary Name: Unblemish Gentle Exfoliating Acne Wash Additional informationCallout TooltipWhat is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Salicylic Acid Additional informationCallout TooltipWhat is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.


Code Structure
  • 14222 - Rodan & Fields
    • 14222-2110 - Unblemish Gentle Exfoliating Acne Wash

NDC 14222-2110-1

Package Description: 1 TUBE in 1 CARTON > 125 mL in 1 TUBE

NDC Product Information

Unblemish Gentle Exfoliating Acne Wash with NDC 14222-2110 is a a human over the counter drug product labeled by Rodan & Fields. The generic name of Unblemish Gentle Exfoliating Acne Wash is salicylic acid. 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 Additional informationCallout TooltipWhat 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.


Unblemish Gentle Exfoliating Acne Wash Active Ingredient(s)

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

  • SALICYLIC ACID .005 g/mL

Inactive Ingredient(s)

Additional informationCallout TooltipAbout 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)
  • COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
  • POTASSIUM COCOYL GLYCINATE (UNII: WZ70FUF22U)
  • SODIUM COCOYL ISETHIONATE (UNII: 518XTE8493)
  • PERLITE (UNII: 0SG101ZGK9)
  • LAURYL GLUCOSIDE (UNII: 76LN7P7UCU)
  • SULFUR (UNII: 70FD1KFU70)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • POTASSIUM COCOATE (UNII: F8U72V8ZXP)
  • CETYL ALCOHOL (UNII: 936JST6JCN)
  • DISTEARYL PHTHALAMIC ACID (UNII: 5552GSZ9LI)
  • HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)
  • PROPANEDIOL (UNII: 5965N8W85T)
  • MYRISTIC ACID (UNII: 0I3V7S25AW)
  • .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
  • AMYLOPECTIN (UNII: 4XO4QFV777)
  • COCONUT ACID (UNII: 40U37V505D)
  • D&C RED NO. 33 (UNII: 9DBA0SBB0L)
  • D&C VIOLET NO. 2 (UNII: 350KA7O6HK)
  • ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
  • GERANIOL (UNII: L837108USY)
  • ICODEXTRIN (UNII: 2NX48Z0A9G)
  • LAURIC ACID (UNII: 1160N9NU9U)
  • LIMONENE, (+)- (UNII: GFD7C86Q1W)
  • LINALOOL, (+/-)- (UNII: D81QY6I88E)
  • NIACINAMIDE (UNII: 25X51I8RD4)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • PHYTOSTERYL/OCTYLDODECYL LAUROYL GLUTAMATE (UNII: 65954KGO9Q)
  • POLYDEXTROSE (UNII: VH2XOU12IE)
  • POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • SODIUM CHLORIDE (UNII: 451W47IQ8X)
  • SODIUM ISETHIONATE (UNII: 3R36J71C17)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • TOCOPHEROL (UNII: R0ZB2556P8)
  • XANTHAN GUM (UNII: TTV12P4NEE)

Administration Route(s)

Additional informationCallout TooltipWhat 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

Additional informationCallout TooltipWhat 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: part333D Additional informationCallout TooltipWhat 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. Additional informationCallout TooltipWhat 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: 02-13-2019 Additional informationCallout TooltipWhat 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: 12-31-2020 Additional informationCallout TooltipWhat 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 Additional informationCallout TooltipWhat 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. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Unblemish Gentle Exfoliating Acne Wash Product Label Images

Unblemish Gentle Exfoliating Acne Wash 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

Salicylic Acid 0.5%

Purpose

Acne treatment

Uses

For the treatment of acne. Helps keep skin clear of new acne blemishes, acne pimples, blackheads and whiteheads.

Warnings

For external use only

Otc - When Using

  • When using this productSkin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne medication at a time.
  • Rinse right away with water if it gets in eyes.

Otc - Stop Use

  • Stop and ask a doctorIf skin irritation occurs or gets worse.

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.

Directions

  • Cover the entire affected area with a thin layer, lather and rinse thoroughly.
  • Because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three times daily if needed or as directed by a doctor.
  • If bothersome dryness or peeling occurs, reduce application to once a day or every other day.

Inactive Ingredients

Water, Cocamidopropyl Betaine, Potassium Cocoyl Glycinate, Sodium Cocoyl lsethionate, Perlite, Lauryl Glucoside, Colloidal Sulfur, Glycerin, Potassium Cocoate, Cetyl Alcohol, Distearyl Phthalic Acid Amide, Hydrogenated Polyisobutene, Acrylates Copolymer, Propanediol, Myristic Acid, Sodium Chloride, Niacinamide, Coconut Acid, Lauric Acid, Sodium lsethionate, Fragrance (Parfum), Phytosteryl/Octyldodecyl Lauroyl Glutamate, Xanthan Gum, Tocopherol, Dextrin, Polydextrose, Amylopectin, Potassium Hydroxide, Propylene Glycol, Ethylhexylglycerin, Phenoxyethanol, Limonene, Linalool, Citronellol, Geraniol, Titanium Dioxide (Cl 77891), Red 33 (Cl 17200), Violet 2 (Cl 60725)

Questions

1-888-995-5656

* Please review the disclaimer below.

Previous Code
14222-2100
Next Code
14222-2120