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Name:Neutrogena On-the-spot Acne Treatment Vanishing Formula
Manufacturer:Neutrogena Corporation
Category:Over-the-counter (OTC) Marketed Drugs


Neutrogena On-the-Spot Acne Treatment

NEUTROGENA ON-THE-SPOT ACNE TREATMENT  VANISHING FORMULA - benzoyl peroxide cream 
Neutrogena Corporation

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Neutrogena On-the-Spot Acne Treatment

Drug Facts

Active ingredient

Benzoyl Peroxide 2.5%

Purpose

Acne medication

Use

For the treatment of acne.

Warnings

For external use only

Do not use if you have very sensitive skin or are sensitive to benzoyl peroxide.

Ask a doctor or pharmacist before use if you are using other topical acne medications at the same time or immediately following use of this product. This may increase dryness or irritation of the skin. If this occurs, only one medication should be used unless directed by a doctor.

When using this product

  • Avoid contact with eyes. If contact occurs, flush thoroughly with water.
  • Keep away from lips and mouth.
  • This product may bleach hair or dyed fabrics

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

Directions

  • Cleanse the skin thoroughly before applying medication.
  • Apply On-the-Spot® directly on acne pimples.
  • 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

  • This product may bleach hair or dyed fabrics.
  • Avoid storage at extreme temperatures (below 40°F and above 100°F)

Inactive ingredients

Water
Bentonite
Caprylic/Capric Triglyceride
Glycerin
Emulsifying Wax NF
Polysorbate 20
Glyceryl Laurate
Cetyl Dimethicone
Magnesium Aluminum Silicate
Xanthan Gum
Sodium Citrate
Disodium EDTA
Citric Acid
Methylparaben
Propylparaben

Questions or comments?

1-800-582-4048 (USA only)

PRINCIPAL DISPLAY PANEL - 21 g Tube Label

VANISHING CREAM FORMULA

On-the-Spot®
Acne Treatment

fights acne-causing bacteria
while gentle on skin

benzoyl peroxide acne medication

MAXIMUM STRENGTH EFFECTIVENESS

Tough on Acne,
Easy on Your Skin

Neutrogena®

DERMATOLOGIST RECOMMENDED

NET WT .75 OZ (21g)

Principal Display Panel

NEUTROGENA ON-THE-SPOT ACNE TREATMENT   VANISHING FORMULA
benzoyl peroxide cream
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:10812-914
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Benzoyl Peroxide (Benzoyl Peroxide) Benzoyl Peroxide 2.5 mg  in 1 g
Inactive Ingredients
Ingredient Name Strength
Water  
Bentonite  
Medium-Chain Triglycerides  
Glycerin  
Polysorbate 20  
Glyceryl Laurate  
Magnesium Aluminum Silicate  
Xanthan Gum  
Sodium Citrate  
Edetate Disodium  
Citric Acid Monohydrate  
Methylparaben  
Propylparaben  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:10812-914-04 1 TUBE ( TUBE) in 1 CARTON contains a TUBE
1 21 g in 1 TUBE This package is contained within the CARTON (10812-914-04)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH NOT FINAL part333D 10/01/2010

Labeler - Neutrogena Corporation (008254617)

Revised: 10/2010 Neutrogena Corporation



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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