NDC 69968-0074 Neutrogena Complete Acne Therapy Solution

Salicylic Acid, Avobenzone, Octisalate, Octocrylene, Oxybenzone, And Benzoyl Peroxide

NDC Product Code 69968-0074

NDC CODE: 69968-0074

Proprietary Name: Neutrogena Complete Acne Therapy Solution 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, Avobenzone, Octisalate, Octocrylene, Oxybenzone, And Benzoyl Peroxide 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.
    • 69968-0074 - Neutrogena Complete Acne Therapy Solution

NDC 69968-0074-9

Package Description: 1 KIT in 1 CARTON * 40 mL in 1 TUBE (10812-975-01) * 50 mL in 1 TUBE (69968-0616-2) * 150 mL in 1 TUBE (69968-0320-5)

NDC Product Information

Neutrogena Complete Acne Therapy Solution with NDC 69968-0074 is a a human over the counter drug product labeled by Johnson & Johnson Consumer Inc.. The generic name of Neutrogena Complete Acne Therapy Solution is salicylic acid, avobenzone, octisalate, octocrylene, oxybenzone, and benzoyl peroxide. The product's dosage form is kit and is administered via form. The RxNorm Crosswalk for this NDC code indicates multiple RxCUI concepts are associated to this product: 1298275, 200009, 562600 and 865105.

Dosage Form: Kit - A packaged collection of related 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.

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)
  • SODIUM METHYL COCOYL TAURATE (UNII: JVL98CG53G)
  • COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
  • SODIUM CHLORIDE (UNII: 451W47IQ8X)
  • GLYCOL DISTEARATE (UNII: 13W7MDN21W)
  • HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
  • GLYCOLIC ACID (UNII: 0WT12SX38S)
  • SODIUM LACTATE (UNII: TU7HW0W0QT)
  • COCAMIDOPROPYL PROPYLENE GLYCOL-DIMONIUM CHLORIDE PHOSPHATE (UNII: H2KVQ74JM4)
  • POLYQUATERNIUM-11 (1000000 MW) (UNII: 0B44BS5IJS)
  • EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
  • CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
  • SODIUM HYDROXIDE (UNII: 55X04QC32I)
  • WATER (UNII: 059QF0KO0R)
  • OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
  • PEG-100 STEARATE (UNII: YD01N1999R)
  • DIMETHICONE (UNII: 92RU3N3Y1O)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
  • CAPRYLYL GLYCOL (UNII: 00YIU5438U)
  • CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)
  • TROLAMINE (UNII: 9O3K93S3TK)
  • METHYLPARABEN (UNII: A2I8C7HI9T)
  • EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
  • ETHYLENE BRASSYLATE (UNII: 9A87HC7ROD)
  • DIPROPYLENE GLYCOL (UNII: E107L85C40)
  • 2,6-DIMETHYL-5-HEPTENAL (UNII: Z331YX9EL9)
  • WATER (UNII: 059QF0KO0R)
  • CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL OR ALLYL SUCROSE CROSSLINKED) (UNII: K6MOM3T5YL)
  • ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
  • SODIUM HYDROXIDE (UNII: 55X04QC32I)
  • CHLORPHENESIN (UNII: I670DAL4SZ)
  • EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
  • LAURETH-4 (UNII: 6HQ855798J)
  • HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)

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: 10-01-2016 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: 12-31-2022 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 - NO 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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

* Please review the disclaimer below.

Information for Patients

Benzoyl Peroxide Topical

Benzoyl Peroxide Topical is pronounced as (ben' zoe il)

Why is benzoyl peroxide topical medication prescribed?
Benzoyl peroxide is used to treat mild to moderate acne....
[Read More]
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 Complete Acne Therapy Solution Product Label Images

Neutrogena Complete Acne Therapy Solution 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

Neutrogena® SKIN POLISHING ACNE CLEANSERDrug Facts

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 protective clothing and limit sun exposure while using this product and for a week afterwards. Store at room temperature.

Neutrogena OIL-FREE MOISTURE WITH SUNSCREEN BROAD SPECTRUM SPF 15Drug Facts

Neutrogena® ACNE CONTROL LOTION Drug Facts

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

Active Ingredient

Salicylic Acid 2%

Avobenzone (1.5%), Octisalate (5%)Octocrylene (3%), Oxybenzone(4%)

Benzyl Peroxide 2.5%

Purpose

Acne treatment

Sunscreen

Acne Medication

Use

  • For the treatment of acne

  • For the treatment of acne

Warnings

For external use only

For external use only

For external use only

Otc - When Using

  • When using this productskin 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.

  • When using this product keep out of eyes. Rinse with water to remove.

  • When using this productskin 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 the same time. If irritation occurs, only use one topical acne medication at a time.

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.

  • Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • Wet face. Squeeze into hands.apply to face and massage gentlyrinse thoroughlyif excessive drying of peeling occurs, reduce application to every other day.

  • For sunscreen useapply liberally and evenly 15 minutes before sun exposurereapply at least every 2 hours.use a water resistant sunscreen if swimming or sweatingSun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging . To decrease this risk, regularly use a sunscreen with a Broad Spectrum value of SPF of 15 or higher and other sun protection measures including:limit time in the sun, especially from 10 a.m. – 2 p.m.wear long-sleeved shirts, pants, hats, and sunglassesChildren under 6 months of age: Ask a doctor

  • Clean the skin thoroughly before applying this product.Cover 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.If going outside, apply sunscreen after using this product. If irritation or sensitivity develops, stop use of both products and ask a doctor.

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, xanthan gum, cocamidopropyl PG-dimonium chloride phosphate, disodium EDTA, menthol, fragrance, benzalkonium chloride, panthenol

Water, octyldodecyl neopentanoate, glycerin, emulsifying wax NF, glyceryl stearate, PEG-100 stearate, dimethicone, phenoxyethanol, ethylhexyglycerin, caprylyl glycol, carbomer, triethanolamine, methylparaben, disodium EDTA, ethylene brassylate, dipropylene glycol, dimethyl heptenal

Water, carbomer homopolymer type B, ethylhexylglycerin, sodium hydroxide, chlorphenesin, disodium EDTA, laureth-4, hydroxypropyl methylcellulose

Questions?

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

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

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

Uses

  • Helps prevent sunburnif used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.

Otc - Do Not Use

  • Do not use on damaged or broken skin

Otc - Stop Use

  • Stop use and ask a doctor if rash occurs.

Other Information

  • Protect this product from excessive heat and direct sunmay stain some fabrics

Do Not Use If You

  • Have very sensitive skinare sensitive to benzoyl peroxide.

When Using This Product

  • Avoid unnecessary sun exposure and use a sunscreenavoid contact with the eyes, lips and mouth.avoid contact with hair or dyed fabrics, which may be bleached by this product.Skin irritation may occur, characterized by redness, burning, itching, peeling, or possibly swelling. Irritation may be reduced by using the product less frequently or in a lower concentration.

Stop Use And Ask A Doctor If

  • Irritation becomes severe.

* Please review the disclaimer below.