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Tera-Gel by Geritrex LLC

Medically reviewed on Jan 19, 2018

Dosage form: shampoo
Ingredients: COAL TAR 0.57g in 114mL
Labeler: Geritrex LLC
NDC Code: 54162-250

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.

Tera-Gel Shampoo

Active Ingredient

Active Ingredient Purpose
0.5% Coal Tar . . . . . . . . . . . . . . . Anti-Dandruff, Anti-Seborrheic
Dermatitis, Anti-Psoriasis

Uses

To control the symptoms of dandruff,
seborrheic dermatitis, and psoriasis

Directions

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

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

Warnings

FOR EXTERNAL USE ONLY
Consult a physician before use if you have a condition that
covers a large area of the body. Consult a physician or pharmacist
before using if you intend to use 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.
• If improvement does not occur, or condition worsens after
regular use, as directed, consult a physician.
• Use caution when exposing skin to sunlight after using this
product. It may increase the tendency to sunburn for up
to 24 hours after using this product.
• Do not use for prolonged periods without consulting a doctor.
If condition worsens or does not improve after regular use of
this product as directed, stop use and consult a physician.

15°-30°C (59°-86°F).

Keep out of reach of children. If swallowed get prompt medical
attention or contact a poison control center immediately.

​Inactive Ingredients:

Citric Acid, Cocamide DEA, Cocamidopropyl Betaine, Deionized Water, DMDM Hydantoin, Fragrance, Methylparaben, Polysorbates 20 & 80, Propylparaben, Sodium Chloride, Sodium Laureth Sulfate, Tetrasodium EDTA

TERA-GEL 
coal tar shampoo
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54162-250
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
COAL TAR (COAL TAR) COAL TAR0.57 g  in 114 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
COCO DIETHANOLAMIDE 
POLYSORBATE 20 
POLYSORBATE 80 
CITRIC ACID MONOHYDRATE 
COCAMIDOPROPYL BETAINE 
DMDM HYDANTOIN 
METHYLPARABEN 
PROPYLPARABEN 
SODIUM CHLORIDE 
SODIUM LAURETH SULFATE 
EDETATE SODIUM 
Packaging
#Item CodePackage Description
1NDC:54162-250-04114 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart358H07/31/2015
Labeler - Geritrex LLC (112796248)

 
Geritrex LLC

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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