Neutrogena Complete Acne Therapy System

Dosage form: kit
Ingredients: Salicylic Acid 5mg in 1mL; Octinoxate 75mg in 1mL, Zinc Oxide 29.4mg in 1mL; Benzoyl Peroxide 25mg in 1mL
Labeler: Neutrogena Corporation
NDC Code: 10812-397

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.

Neutrogena® Complete Acne Therapy System

Neutrogena Advanced Solutions Skin Polishing Acne Cleanser

Drug Facts

Active ingredient

Salicylic Acid 0.5%

Purpose

Acne treatment

Use

For the treatment of acne.

Warnings

For external use only

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 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 gently
  • Rinse thoroughly
  • If excessive drying or peeling occurs, reduce application to every other day

Other Information

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 and limit sun exposure while using this product and for a week afterwards.

Inactive ingredients

Water
Sodium Methyl Cocoyl Taurate
Cocamidopropyl Betaine
Sodium Cocoamphoacetate
Glycol Distearate
Polyethylene
Glycolic Acid
Sodium Lactate
Cocamidopropyl PG-Dimonium Chloride Phosphate
Polyquaternium-11
Disodium EDTA
Fragrance

Neutrogena Acne Control

Drug Facts

Active ingredient

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.

Do not use if you

  • have very sensitive skin
  • are sensitive to benzoyl peroxide

When using this product
  • avoid unnecessary sun exposure and use sunscreen
  • avoid contact with the eyes, lips, and mouth
  • avoid contact with hair and dyed products, 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

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

Inactive ingredients

Water, Carbomer, Sodium Hydroxide, Laureth-4, Hydroxypropyl Methylcellulose, Disodium EDTA

Questions or comments?

(USA only) 1-800-582-4048 or www.neutrogena.com

Avoid storage at extreme temperatures (below 40°F and above 100°F).

Neutrogena Advanced Solutions Oil Free SPF15

Drug Facts

Active ingredientsPurpose
Octinoxate 7.5%Sunscreen
Zinc Oxide 2.94%.Sunscreen

Use

Helps prevent sunburn

Warnings

For external use only

When using this product avoid contact with eyes. If contact occurs, flush thoroughly with water.

Stop use and ask a doctor if irritation or rash develops and lasts.

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

Directions
  • Before sun exposure and as needed, apply liberally on face, neck and other exposed areas every morning after cleansing
  • Perfect alone or under make-up
  • Children under 6 months of age: ask a doctor

Inactive ingredients

Water, Glycerin, Pentylene Glycol, Cetearyl Alcohol, Portulaca Oleracea Extract, Butylene Glycol, Capryloyl Glycine, Dicetyl Phosphate, Glyceryl Stearate, PEG-100 Stearate, Caprylyl Methicone, Sarcosine, Cinnamomum Zeylanicum Bark Extract, Hexylene Glycol , Cedrus Atlantica Bark Extract, Propylene Glycol, Triethoxycaprylylsilane , Ceteth-10 Phosphate, Methylparaben, Propylparaben, Ethylparaben, Isopropylparaben, Isobutylparaben, Butylparaben, Disodium EDTA Xanthan Gum, Fragrance

Questions or comments?

1-800-582-4048 (USA only)

Dist. by Neutrogena Corporation, Los Angeles, CA 90045

PRINCIPAL DISPLAY PANEL - Kit Carton Label

#1 DERMATOLOGIST
RECOMMENDED
ACNE KIT

works
FASTER
than
Proactiv®

complete acne therapy
system

EDITORS CHOICE AWARD
Allure
THE BEAUTY EXPERT
2009

starts clearing breakouts in just 2 days
approximately 2 months supply

Neutrogena®

salicylic acid acne treatment cleanser 5.1 FL OZ (150mL) spf 15 lotion 1.7 FL OZ (50mL)
benzoyl peroxide acne medicine lotion 1.4 FL OZ (40mL)

NEUTROGENA COMPLETE ACNE THERAPY SYSTEM 
salicylic acid, octinoxate, zinc oxide, and benzoyl peroxide kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10812-397
Packaging
#Item CodePackage Description
1NDC:10812-397-901 KIT in 1 CARTON
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 TUBE 150 mL
Part 21 TUBE 50 mL
Part 31 TUBE 40 mL
Part 1 of 3
NEUTROGENA ADVANCED SOLUTIONS SKIN POLISHING ACNE CLEANSER 
salicylic acid lotion
Product Information
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Salicylic Acid (Salicylic Acid) Salicylic Acid5 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
Water 
Sodium Methyl Cocoyl Taurate 
Cocamidopropyl Betaine 
Glycol Distearate 
High Density Polyethylene 
Glycolic Acid 
Sodium Lactate 
Cocamidopropyl PG-Dimonium Chloride Phosphate 
Edetate Disodium 
Packaging
#Item CodePackage Description
1150 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart333D05/23/201203/15/2016
Part 2 of 3
NEUTROGENA ADVANCED SOLUTIONS OIL FREE SPF15 
octinoxate and zinc oxide lotion
Product Information
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Octinoxate (Octinoxate) Octinoxate75 mg  in 1 mL
Zinc Oxide (Zinc Oxide) Zinc Oxide29.4 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
Water 
Glycerin 
Pentylene Glycol 
Cetostearyl Alcohol 
Purslane 
Butylene Glycol 
Capryloyl Glycine 
Dihexadecyl Phosphate 
Glyceryl Monostearate 
PEG-100 Stearate 
Sarcosine 
Cinnamon Bark Oil 
Hexylene Glycol 
Cedrus Atlantica Bark 
Propylene Glycol 
Triethoxycaprylylsilane 
Ceteth-10 Phosphate 
Methylparaben 
Propylparaben 
Ethylparaben 
Isopropylparaben 
Isobutylparaben 
Butylparaben 
Edetate Disodium 
Xanthan Gum 
Packaging
#Item CodePackage Description
150 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35205/23/201203/15/2016
Part 3 of 3
NEUTROGENA ACNE CONTROL 
benzoyl peroxide lotion
Product Information
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Benzoyl Peroxide (Benzoyl Peroxide) Benzoyl Peroxide25 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
Water 
Sodium Hydroxide 
Laureth-4 
Edetate Disodium 
Packaging
#Item CodePackage Description
140 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart333D05/23/201203/15/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart333D05/23/201203/15/2016
Labeler - Neutrogena Corporation (008254617)

Revised: 03/2014
 
Neutrogena Corporation

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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