NDC 69968-0472 Neutrogena Rapid Clear Acne Eliminating Spot

Salicylic Acid

NDC Product Code 69968-0472

NDC CODE: 69968-0472

Proprietary Name: Neutrogena Rapid Clear Acne Eliminating Spot What 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 What 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.

NDC Code Structure

  • 69968 - Johnson & Johnson Consumer Inc.
    • 69968-0472 - Neutrogena Rapid Clear Acne Eliminating Spot

NDC 69968-0472-1

Package Description: 1 TUBE in 1 CARTON > 15 mL in 1 TUBE

NDC Product Information

Neutrogena Rapid Clear Acne Eliminating Spot with NDC 69968-0472 is a a human over the counter drug product labeled by Johnson & Johnson Consumer Inc.. The generic name of Neutrogena Rapid Clear Acne Eliminating Spot is salicylic acid. The product's dosage form is gel and is administered via topical form.

Labeler Name: Johnson & Johnson Consumer Inc.

Dosage Form: Gel - A semisolid3 dosage form that contains a gelling agent to provide stiffness to a solution or a colloidal dispersion.4 A gel may contain suspended particles.

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.

Neutrogena Rapid Clear Acne Eliminating Spot 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 20 mg/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.

  • WATER (UNII: 059QF0KO0R)
  • HAMAMELIS VIRGINIANA TOP WATER (UNII: NT00Y05A2V)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
  • C13-14 ISOPARAFFIN (UNII: E4F12ROE70)
  • C12-15 ALKYL LACTATE (UNII: GC844VRD7E)
  • ALCOHOL (UNII: 3K9958V90M)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • CETYL LACTATE (UNII: A7EVH2RK4O)
  • PPG-2 ISOCETETH-20 ACETATE (UNII: BI6C7YO419)
  • COCAMIDOPROPYL PROPYLENE GLYCOL-DIMONIUM CHLORIDE PHOSPHATE (UNII: H2KVQ74JM4)
  • LAURETH-7 (UNII: Z95S6G8201)
  • POLYSORBATE 20 (UNII: 7T1F30V5YH)
  • DEHYDROXANTHAN GUM (UNII: 63ZP7I1BQO)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
  • AMMONIA (UNII: 5138Q19F1X)
  • EDETATE SODIUM (UNII: MP1J8420LU)
  • BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
  • CAPRYLOYL GLYCINE (UNII: 8TY5YO42NJ)
  • SARCOSINE (UNII: Z711V88R5F)
  • CINNAMON BARK OIL (UNII: XE54U569EC)
  • CEDRUS ATLANTICA BARK (UNII: ITP1Q41UPF)
  • PURSLANE (UNII: M6S840WXG5)

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: Johnson & Johnson Consumer Inc.
Labeler Code: 69968
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: 10-30-2019 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: 12-31-2020 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.

Neutrogena Rapid Clear Acne Eliminating Spot Product Label Images

Neutrogena Rapid Clear Acne Eliminating Spot 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

Other

Drug Facts

Distributed by:JOHNSON & JOHNSONCONSUMER INC. Skillman, NJ 08558

Active Ingredient

Salicylic Acid 2%

Purpose

Acne Medication

Use

For the treatment of acne.

Warnings

For external use only.

Flammable

Keep away from fire or flame.

When Using This Product

  • Skin irritation and dryness is more likely to occour if you use another tropical acne medication at the same time. If irritation occurs, only use one topical medication at a time

Otc - Keep Out Of Reach Of Children

  • If eye contact occurs, flush thoroughly with water. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • Cleanse the skin thoroughly before applying product.cover the entire affected area with a thin layer 1-3 times daily.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 every other day.

Sunburn Alert

This product contains an alpha hydroxy acid (AHA) that may increase your skin's sensitivity to the sun and particularly the possibility of sunburn. Use a sunscreen, wear a protective clothing, and limit sun exposure while using this product and for a week afterwards. Store at Room Temperature.

Inactive Ingredients

Water, alcohol denat., hamamelis virginiana (witch hazel) water, polyacrylamide, glycerin, cyclopentasiloxane, C13-14 isoparaffin, C12-15 alkyl lactate, alcohol, phenoxyethanol, cetyl lactate, PPG-2 isoceteth-20 acetate, cocamidopropyl PG-dimonium chloride phosphate, laureth-7, polysorbate 20, phenethyl dimethicone, fragrance, dehydroxanthan gum, propylene glycol, benzalkonium chloride, ammonia, tetrasodium EDTA, butylene glycol, capryloyl glycine, sarcosine, cinnamomum zeylanicum bark extract, cedrus atlantica bark extract, portulaca oleracea extract

Questions?

800-299-4786; Outside US dial collect US, 215-273-8755 or www.neutrogena.com

* Please review the disclaimer below.