FDA Label for Anti-dandruff

View Indications, Usage & Precautions

Anti-dandruff Product Label

The following document was submitted to the FDA by the labeler of this product Strategic Sourcing Services Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Active Ingredient



2.5% Coal Tar Topical Solution
(0.5% Coal Tar)


Purpose



Anti-Dandruff


Use



controls the symptoms of: 

  • dandruff
  • seborrheic dermatitis
  • psoriasis

Warnings



For external use only


Ask A Doctor Before Use If You Have



a condition which covers a large part of the body


When Using This Product



•do not get into eyes.  If contact occurs, rinse eyes thoroughly with water.
•use caution in 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
•do not use with other forms of psoriasis therapy such as ultraviolet radiation or prescription drugs unless directed to do so by a doctor.


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



•wet hair thoroughly
•massage shampoo into scalp
•lather.  Leave on hair and scalp for several minutes
•rinse and repeat
•for best results use at least twice a week or as directed by a doctor


Other Information



•store away from direct sunlight
•in rare instances, discoloration of gray, blonde, bleached, or tinted hair may occur


Inactive Ingredients



water, sodium laureth sulfate, cocamide MEA, laureth-4, fragrance, sodium chloride, cocamidopropyl betaine, methylchloroisothiazolinone, methylisothiazolinone, citric acid, tetrasodium EDTA, caramel, red 4


Disclaimer



This product is not manufactured or distributed by the Neutorgena Corporation, distributor of  T/Gel Shampoo


Adverse Reaction



Another Quality Product
Distributed by McKesson
One Post Street
San Francisco, CA 94104
Money Back guarantee
Please visit us at www.sunmarkbrand.com

205.000/205AG


Principal Display Panel



sunmark

COMPARE TO

ACTIVE INGREDIENT

OF T/GEL SHAMPOO

NDC 49348-602-47

coal tar

anti-dandruff

shampoo

Therapeutic

2.5% Coal Tar

Topical Solution USP

(0.5% Coal Tar)

Controls the symptoms

 of psoriasis, seborrheic

dermatitis & dandruff

FIGHTS ITCHY, FLAKY SCALP

8.5 FL OZ

(251 mL)


* Please review the disclaimer below.