Neutrogena On-the-spot Acne Treatment Cream
FDA Label NDC 69968-0164

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Kenvue Brands Llc for the product Neutrogena On-the-spot Acne Treatment (NDC 69968-0164). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, active ingredients, purpose, use, warnings, when using this product, do not use if you, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

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

Active Ingredients

Benzoyl Peroxide (2.5%)

Purpose

Acne Medication

Use

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 unnecessary sun exposure and use a sunscreen.
    • Avoid 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.

Do Not Use If You

  • Have very sensitive skin.
  • Are sensitive to benzoyl peroxide.

Stop Use And Ask A Doctor If

  • Irritation becomes severe.

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 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.

Other Information

  • Store at 20°C to 25°C (68°F - 77° F)

Inactive Ingredients

Water, Carbomer Homopolymer type B, Ethylhexylglycerin, Sodium Hydroxide, Chlorphenesin, Disodium EDTA, Laureth-4, Hydroxypropyl Methylcellulose

Questions?

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

Principal Display Panel - 21G Tube Carton

VANISHING CREAM FORMULA

On-the-Spot ®
Acne Treatment

fights acne-causing bacteria
while gentle on skin

benzoyl peroxide acne medication
CLINICALLY PROVEN POWER
Tough on Acne,
Easy on Your Skin

Neutrogena ®

DERMATOLOGIST RECOMMENDED

NET WT .75 OZ (21g)

Principal Display Panel (21g Tube Carton)

Principal Display Panel (21g Tube Carton)

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