NDC 69968-0519 Neutrogena Oil-free Acne Stress Control Power-cream Wash

Salicylic Acid

NDC Product Code 69968-0519

NDC Code: 69968-0519

Proprietary Name: Neutrogena Oil-free Acne Stress Control Power-cream Wash 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.
    • 69968-0519 - Neutrogena Oil-free Acne Stress Control Power-cream Wash

NDC 69968-0519-6

Package Description: 177 mL in 1 TUBE

NDC Product Information

Neutrogena Oil-free Acne Stress Control Power-cream Wash with NDC 69968-0519 is a a human over the counter drug product labeled by Johnson & Johnson Consumer Inc.. The generic name of Neutrogena Oil-free Acne Stress Control Power-cream Wash is salicylic acid. The product's dosage form is cream and is administered via topical form.

Labeler Name: Johnson & Johnson Consumer Inc.

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.

Neutrogena Oil-free Acne Stress Control Power-cream Wash 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)
  • CETYL ALCOHOL (UNII: 936JST6JCN)
  • PPG-15 STEARYL ETHER (UNII: 1II18XLS1L)
  • GLYCOLIC ACID (UNII: 0WT12SX38S)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • POLYSORBATE 60 (UNII: CAL22UVI4M)
  • STEARETH-21 (UNII: 53J3F32P58)
  • C12-15 ALKYL LACTATE (UNII: GC844VRD7E)
  • CETYL LACTATE (UNII: A7EVH2RK4O)
  • POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)
  • SODIUM HYDROXIDE (UNII: 55X04QC32I)
  • COCAMIDOPROPYL PROPYLENE GLYCOL-DIMONIUM CHLORIDE PHOSPHATE (UNII: H2KVQ74JM4)
  • XANTHAN GUM (UNII: TTV12P4NEE)
  • EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
  • MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)
  • BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
  • PANTHENOL (UNII: WV9CM0O67Z)
  • GREEN TEA LEAF (UNII: W2ZU1RY8B0)
  • BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
  • CUCUMBER (UNII: YY7C30VXJT)
  • D&C GREEN NO. 5 (UNII: 8J6RDU8L9X)
  • FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
  • 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: 03-30-2019 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 Oil-free Acne Stress Control Power-cream Wash Product Label Images

Neutrogena Oil-free Acne Stress Control Power-cream 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

Other

Drug Facts

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

Active Ingredient

Salicylic Acid 2%

Purpose

Acne treatment

Use

For the treatment of acne.

Warnings

For external use only.

Otc - When Using

  • 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

  • Cleanse face twice a day.Wet face and squeeze cleanser into hands.Apply to face and massage gently, avoiding contact with delicate eye area.Rinse thoroughly.

Other Information

Store at Room Temperature.

Inactive Ingredients

Water, Cetyl Alcohol, PPG-15 Stearyl Ether, Glycolic Acid, Glycerin, Polysorbate 60, Steareth-21, C12-15 Alkyl Lactate, Cetyl Lactate, Potassium Cetyl Phosphate, Sodium Hydroxide, Cocamidopropyl PG-Dimonium Chloride Phosphate, Fragrance, Xanthan Gum, Disodium EDTA, Menthol, Benzalkonium Chloride, Panthenol, Camellia Sinensis Leaf Extract, Butylene Glycol, Cucumus Sativus (Cucumber) Fruit Extract, Green 5, Yellow 5, Blue 1

Questions?

Call toll-free 800-582-4048 or 215-273-8755 (collect). www.neutrogena.com

* Please review the disclaimer below.

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