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Name:Neutrogena T/gel Therapeutic
Manufacturer:Neutrogena Corporation
Category:Over-the-counter (OTC) Marketed Drugs


Neutrogena T/Gel Therapeutic Shampoo Kit

NEUTROGENA T/GEL THERAPEUTIC - salicylic acid   
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 T/Gel Therapeutic Shampoo Kit

Neutrogena T/Gel Therapeutic Shampoo Kit: Day 1

Drug Facts

Active ingredient

Salicylic Acid 3.0%

Purpose

Anti-dandruff, anti-seborrheic dermatitis, anti-psoriasis

Use

Controls the symptoms of dandruff, seborrheic dermatitis and psoriasis.

Warnings

For external use only

Ask a doctor before use if you have a condition that covers a large area of the body.

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

Stop use and ask a doctor if condition worsens or does not improve after regular use of this product as directed.

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

Directions

  • For best results, use at least twice a week or as directed by a physician
  • Wet hair thoroughly
  • Massage liberal amount of shampoo into the scalp
  • Leave lather on scalp for several minutes
  • Rinse and repeat

Inactive ingredients

Water, Cocamidopropyl Betaine, Sodium C14-16 Olefin Sulfonate, Linoleamidopropyl PG-Dimonium Chloride, Phosphate, Sodium Lauroyl Sarcosinate, Polyquaternium-22, Hexylene Glycol, Sodium Citrate

Questions or comments?

(USA) 1-877-256-4247 or www.tgel.com

Neutrogena T/Gel Therapeutic Shampoo Kit: Day 2

Drug Facts

Active ingredient

Coal Tar 1.0%

Purpose

Anti-dandruff, anti-seborrheic dermatitis, anti-psoriasis

Use

Controls the symptoms of dandruff, seborrheic dermatitis and psoriasis.

Warnings

For external use only

Ask a doctor before use if you have a condition that covers a large area of the body.

Ask a doctor or pharmacist before use if you are using this product with other forms of psoriasis therapy such as ultraviolet radiation or prescription drugs.

When using this product

  • Avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water.
  • Use caution when exposing skin to sunlight after applying this product. It may increase your tendency to sunburn for up to 24 hours after application.
  • Do not use for prolonged periods without consulting a doctor.

STATE OF CALIFORNIA PROPOSITION 65 WARNING, AS APPROVED PER APROPRIATE SKU 1


1
Not necessary when sold outside of California

Stop use and ask a doctor if condition worsens or does not improve after regular use of this product as directed.

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

Directions

For best results, use at least twice a week or as directed by a doctor.

  • Wet hair thoroughly.
  • Massage shampoo into your scalp.
  • Lather, leaving on your hair and scalp for several minutes.
  • Rinse and repeat.

Inactive ingredients

Water, Sodium Laureth Sulfate, Polysorbate-20, Laureth-4, Cocamidopropyl Betaine, Cocamide MEA, Bishydroxyethyl Dihydroxypropyl Stearammonium, Chloride, PEG-120 Methyl Glucose Dioleate, Tetrasodium EDTA, Citric Acid, DMDM Hydantoin, Fragrance

Questions or comments?

(USA) 1-877-256-4247 or www.tgel.com

Store away from direct sunlight. In rare instances, discoloration of gray, blonde, bleached, or tinted hair may occur. § 201.66 (c)(7)

Neutrogena T/Gel Therapeutic Shampoo Kit: Day 3

Drug Facts

Active ingredient

Pyrithione Zinc 1%

Purpose

Anti-Dandruff, Anti-Seborrheic Dermatitis

Use

Controls the symptoms of Dandruff and Seborrheic Dermatitis

Warnings

For external use only

Ask a doctor before use if you have a condition that covers a large area of the body.

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

Stop use and ask a doctor if condition worsens or does not improve after regular use of this product as directed.

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

Directions

For best results, use at least twice a week or as directed by a physician.

  • Wet hair thoroughly.
  • Massage a liberal amount into your scalp.
  • Leave lather on scalp for several minutes.
  • Rinse and repeat.

Inactive ingredients

Water, sodium Laureth Sulfate, Cocamidopropyl Betaine, Ammonium Lauryl Sulfate, Sodium Methyl Cocoyl Taurate, Divinyldimethicone/Dimethicone Copolymer, C12-13 Pareth-3, C12-13 Pareth-23, Castor Isostearate Succinate, Guar Hydroxypropyltrimonium Chloride, Hydrolyzed Wheat Protein PG Propyl Silanetriol, tocopheryl Acetate, Amodimethicone, Cetearyl Alcohol, Ceteareth-20, Castor Isostearate Succinate, Sodium Hydroxide, Sodium Chloride, Acrylates Copolymer, DMDM Hydantoin, Blue 1, Fragrance

Questions or comments?

(USA) 1-877-256-4247 or www.tgel.com

PRINCIPAL DISPLAY PANEL - 177 mL Kit Carton

NEW

NEUTROGENA®
T/Gel®
therapeutic
shampoo

Dermatologist Strength Scalp Treatments

helps eliminate & prevent dryness, flaking & itching

DAY 1 salicylic acid clears flaky scalp build up
DAY 2 coal tar controls persistent itching & flaking
DAY 3 pyrithione zinc treats & nourishes scalp
REPEAT rotation until symptoms subside

#1 DERMATOLOGIST RECOMMENDED BRAND

Neutrogena®

Approximately 5 full rotations
3 Individual 2 FL OZ (59 mL) Bottles – Total 6 FL OZ (177 mL)

Principal Display Panel - 177 mL Kit Carton

NEUTROGENA T/GEL THERAPEUTIC 
salicylic acid kit
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:10812-407
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:10812-407-90 1 KIT ( KIT) in 1 PACKAGE, COMBINATION None
QUANTITY OF PARTS
Part # Package Quantity Total Product Quantity
Part 1 1 BOTTLE   59 mL
Part 2 1 BOTTLE   59 mL
Part 3 1 BOTTLE   59 mL
Part 1 of 3
DAY 1 
salicylic acid shampoo
Product Information
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Salicylic Acid (Salicylic Acid) Salicylic Acid 30 mg  in 1 mL
Inactive Ingredients
Ingredient Name Strength
water  
Cocamidopropyl Betaine  
Sodium C14-16 Olefin Sulfonate  
Sodium Lauroyl Sarcosinate  
Hexylene Glycol  
Sodium Citrate  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 59 mL in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part358H 12/01/2010

Part 2 of 3
DAY 2 
coal tar shampoo
Product Information
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Coal Tar (Coal Tar) Coal Tar 10 mg  in 1 mL
Inactive Ingredients
Ingredient Name Strength
water  
Sodium Laureth Sulfate  
Polysorbate 20  
Laureth-4  
Cocamidopropyl Betaine  
COCO MONOETHANOLAMIDE  
PEG-120 Methyl Glucose Dioleate  
EDETATE SODIUM  
Citric Acid Monohydrate  
DMDM Hydantoin  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 59 mL in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part358H 12/01/2010

Part 3 of 3
DAY 3 
pyrithione zinc shampoo
Product Information
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Pyrithione Zinc (Pyrithione Zinc) Pyrithione Zinc 10 mg  in 1 mL
Inactive Ingredients
Ingredient Name Strength
water  
Sodium Laureth Sulfate  
Cocamidopropyl Betaine  
Ammonium Lauryl Sulfate  
.Alpha.-Tocopherol Acetate, D-  
Cetostearyl Alcohol  
POLYOXYL 20 CETOSTEARYL ETHER  
sodium Hydroxide  
Sodium Chloride  
DMDM Hydantoin  
FD&C BLUE NO. 1  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 59 mL in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part358H 12/01/2010


Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part358H 12/01/2010

Labeler - Neutrogena Corporation (008254617)

Revised: 09/2010 Neutrogena Corporation



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


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