NDC 69968-0379 Clean And Clear Blackhead Eraser Scrubby Gel

Salicylic Acid

NDC Product Code 69968-0379

NDC Code: 69968-0379

Proprietary Name: Clean And Clear Blackhead Eraser Scrubby Gel 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.
    • 69968-0379 - Clean And Clear Blackhead Eraser Scrubby Gel

NDC 69968-0379-6

Package Description: 6 STRIP in 1 CARTON

NDC Product Information

Clean And Clear Blackhead Eraser Scrubby Gel with NDC 69968-0379 is a a human over the counter drug product labeled by Johnson & Johnson Consumer Inc.. The generic name of Clean And Clear Blackhead Eraser Scrubby Gel is salicylic acid. The product's dosage form is strip and is administered via topical form.

Labeler Name: Johnson & Johnson Consumer Inc.

Dosage Form: Strip - A long narrow piece of material.

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.

Clean And Clear Blackhead Eraser Scrubby Gel 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/1

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.

  • POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)
  • SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U)
  • COCAMIDOPROPYL HYDROXYSULTAINE (UNII: 62V75NI93W)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • WATER (UNII: 059QF0KO0R)
  • GLYCOLIC ACID (UNII: 0WT12SX38S)
  • MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)
  • SODIUM HYDROXIDE (UNII: 55X04QC32I)
  • MENTHYL LACTATE, (-)- (UNII: 2BF9E65L7I)
  • EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
  • CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
  • D&C RED NO. 33 (UNII: 9DBA0SBB0L)
  • FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

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: 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: 03-01-2019 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.

Clean And Clear Blackhead Eraser Scrubby Gel Product Label Images

Clean And Clear Blackhead Eraser Scrubby Gel 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 Ingredients

Salicylic Acid 2%

Purpose

Acne treatment

Uses

  • For the treatment of acne.

Warnings

For external use only.

When Using This Product

  • Skin 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.avoid contact with eyes. If contact occurs, flush thoroughly with water.

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

Wash face. With dry hands, apply gel strip to damp nose. Wait 1-2minutes. Wet the strip to transform into scrub. Gently massage to exfoliate. Rinse thoroughly. Gentle enough to use once a day.

Other Information

  • Protect from Excessive Heat (50°C to 120°F or higher)

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.

Inactive Ingredients

Polyvinyl Alcohol, Cellulose, Sodium C14-16 Olefin Sulfonate, Cocamidopropyl Hydroxysultaine, Glycerin, Water, Glycolic Acid, Menthol, Fragrance, Sodium Hydroxide, Menthyl Lactate, Disodium EDTA, Citric Acid, Red 33, Blue 1

Questions?

Call toll- free 1-877-754-6411 or 215-273-8755 (collect). www.cleanandclear.com

* Please review the disclaimer below.

Previous Code
69968-0378
Next Code
69968-0382