NDC 10812-975 Neutrogena Acne Control

Benzoyl Peroxide

NDC Product Code 10812-975

NDC CODE: 10812-975

Proprietary Name: Neutrogena Acne Control 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: 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.

Drug Use Information

Drug Use Information
The drug use information is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate. This information is not individual medical advice and does not substitute for the advice of a health care professional. Always ask a health care professional for complete information about this product and your specific health needs.

  • This medication is used to treat mild to moderate acne. It may be used in combination with other acne treatments. When applied to the skin, benzoyl peroxide works by reducing the amount of acne-causing bacteria and by causing the skin to dry and peel. Check the ingredients on the label even if you have used the product before. The manufacturer may have changed the ingredients. Also, products with similar names may contain different ingredients meant for different purposes. Taking the wrong product could harm you.

NDC Code Structure

  • 10812 - Johnson & Johnson Consumer Inc.

NDC 10812-975-01

Package Description: 40 mL in 1 TUBE

NDC Product Information

Neutrogena Acne Control with NDC 10812-975 is a a human over the counter drug product labeled by Johnson & Johnson Consumer Inc.. The generic name of Neutrogena Acne Control is benzoyl peroxide. The product's dosage form is lotion and is administered via topical form. The RxNorm Crosswalk for this NDC code indicates multiple RxCUI concepts are associated to this product: 1298275, 200009, 562600 and 865105.

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 Acne Control 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.


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: 10812
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: 03-14-2014 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....
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* Please review the disclaimer below.

Neutrogena Acne Control Product Label Images

Neutrogena Acne Control 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.