NDC 69968-0193 Neutrogena Oil Free Acne Moisturizer Pink Grapefruit

Salicylic Acid

NDC Product Code 69968-0193

NDC Code: 69968-0193

Proprietary Name: Neutrogena Oil Free Acne Moisturizer Pink Grapefruit 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.


Code Structure
  • 69968 - Johnson & Johnson Consumer Inc.
    • 69968-0193 - Neutrogena Oil Free Acne Moisturizer Pink Grapefruit

NDC 69968-0193-1

Package Description: 14 mL in 1 TUBE

NDC 69968-0193-4

Package Description: 118 mL in 1 BOTTLE, PUMP

NDC Product Information

Neutrogena Oil Free Acne Moisturizer Pink Grapefruit with NDC 69968-0193 is a a human over the counter drug product labeled by Johnson & Johnson Consumer Inc.. The generic name of Neutrogena Oil Free Acne Moisturizer Pink Grapefruit is salicylic acid. The product's dosage form is lotion and is administered via topical form.

Labeler Name: Johnson & Johnson Consumer Inc.

Dosage Form: Lotion - An emulsion, liquid1 dosage form. This dosage form is generally for external application to the skin.2

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 Moisturizer Pink Grapefruit 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 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)
  • DICAPRYLYL ETHER (UNII: 77JZM5516Z)
  • CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • NEOPENTYL GLYCOL DIETHYLHEXANOATE (UNII: U68ZV6W62C)
  • DIMETHICONE (UNII: 92RU3N3Y1O)
  • METHYL GLUCETH-20 (UNII: J3QD0LD11P)
  • ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)
  • CETETH-10 PHOSPHATE (UNII: 4E05O5N49G)
  • DIHEXADECYL PHOSPHATE (UNII: 2V6E5WN99N)
  • STEARETH-20 (UNII: L0Q8IK9E08)
  • STEARETH-2 (UNII: V56DFE46J5)
  • NEOPENTYL GLYCOL DIISOSTEARATE (UNII: 4M6OQ34JWW)
  • SODIUM BENZOATE (UNII: OJ245FE5EU)
  • SODIUM HYDROXIDE (UNII: 55X04QC32I)
  • EDETATE DISODIUM (UNII: 7FLD91C86K)
  • XANTHAN GUM (UNII: TTV12P4NEE)
  • MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)
  • BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
  • PUMMELO (UNII: ET1TN5W71X)

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: 04-02-2019 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.

Information for Patients

Salicylic Acid Topical

Salicylic Acid Topical is pronounced as (sal'' i sil' ik as' id)

Why is salicylic acid topical medication prescribed?
Topical salicylic acid is used to help clear and prevent pimples and skin blemishes in people who have acne. Topical salicylic acid is also used to treat skin conditions ...
[Read More]

* Please review the disclaimer below.

Neutrogena Oil Free Acne Moisturizer Pink Grapefruit Product Label Images

Neutrogena Oil Free Acne Moisturizer Pink Grapefruit 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 0.5%

Purpose

Acne Medication

Use

For the management 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.Rinse right away with water if it gets in eyes.

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

  • Clean the skin thoroughly before applying this productCover the entire affected area with a thin layer one to three 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 once a day or every other day.

Other Information

Store at Room Temperature

Inactive Ingredients

Water, dicaprylyl ether, cetearyl alcohol, glycerin, neopentyl glycol diethylhexanoate, dimethicone, methyl gluceth-20, aluminum starch octenylsuccinate, ceteth-10 phosphate, dicetyl phosphate, steareth-20, steareth-2, neopentyl glycol diisostearate, sodium benzoate, fragrance, sodium hydroxide, disodium EDTA, xanthan gum, magnesium aluminum silicate, BHT, citrus grandis (grapefruit) fruit extract

Questions?

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

* Please review the disclaimer below.

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