NDC 68828-289 Clear Smart Clear Complexion Toner

Salicylic Acid

NDC Product Information

Clear Smart Clear Complexion Toner with NDC 68828-289 is a a human over the counter drug product labeled by Jafra Cosmetics International Inc. The generic name of Clear Smart Clear Complexion Toner is salicylic acid. The product's dosage form is liquid and is administered via topical form.

Labeler Name: Jafra Cosmetics International Inc

Dosage Form: Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.

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.

Clear Smart Clear Complexion Toner 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.

  • SALICYLIC ACID .5 g/100mL

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.

  • HONEY (UNII: Y9H1V576FH)
  • NIACINAMIDE (UNII: 25X51I8RD4)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • HAMAMELIS VIRGINIANA TOP (UNII: UDA30A2JJY)
  • MALTODEXTRIN (UNII: 7CVR7L4A2D)
  • PPG-26-BUTETH-26 (UNII: 2II1K6TZ4P)
  • POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)
  • PHENYLETHYL ALCOHOL (UNII: ML9LGA7468)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)
  • SODIUM HYDROXIDE (UNII: 55X04QC32I)
  • WATER (UNII: 059QF0KO0R)
  • DIPROPYLENE GLYCOL (UNII: E107L85C40)
  • LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
  • MENTHYL LACTATE, (-)- (UNII: 2BF9E65L7I)
  • ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
  • ROYAL JELLY (UNII: L497I37F0C)
  • ALLANTOIN (UNII: 344S277G0Z)
  • BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
  • EDETATE DISODIUM (UNII: 7FLD91C86K)
  • SHEA BUTTER (UNII: K49155WL9Y)

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.
  • 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: Jafra Cosmetics International Inc
Labeler Code: 68828
FDA Application Number: part333D 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: 05-07-2020 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 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. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Clear Smart Clear Complexion Toner Product Label Images

Clear Smart Clear Complexion Toner 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

Otc - Active Ingredient

Active ingredient PurposeSalicylic Acid 0.5% Acne treatment tonic

Otc - Purpose

UsesTreats acnedries up acne pimpleshelps prevent new acne pimples

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.

Indications & Usage

  • When using this productUsing other topical acne medication at the same time or immediately following the use of this product may increase dryness of irritation of the skin. If this occurs, only one medication should be used unless directed by a doctor.

Warnings

For external use only

Dosage & Administration

  • DirectionsClean the skin thoroughly before applyingCover the entire affected area with a thin layer 1 to 3 times dailyAvoid contact with eyes.Becuase excessive drying may of the skin may occur, start with 1 application daily if needed or as directed by a doctorIf bothersome dryness or peeling occurs, reduce application to once a day or every other day.

Inactive Ingredient

Inactive ingredientsAllantoin, Butylene Glycol, Butyrospermum Parkii (Shea) Butter, Dipropylene Glycol, Disodium EDTA, Ethylhexylglycerin, Glycerin, Hamamelis Virginiana (Witch Hazel) Extract, Honey Extract, Hydrogenated Lecithin, Lecithin, Maltodextrin, Menthyl Lactate, Niacinamide, PEG-40 Hydrogenated Castor Oil, Phenethyl Alcohol, Phenoxyethanol, PPG-26-Buteth-26, Royal Jelly Powder, Royal Jelly, SD Alcohol 40-B, Sodium Hydroxide, Tetrapeptide-45, Water/Aqua, Zymomonas Ferment Extract

* Please review the disclaimer below.