TERA-GEL- coal tar shampoo 
Geritrex LLC

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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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

PACKAGE LABEL

TERA-GEL 
coal tar shampoo
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54162-250
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
COAL TAR (UNII: R533ESO2EC) (COAL TAR - UNII:R533ESO2EC) COAL TAR0.57 g  in 114 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
COCO DIETHANOLAMIDE (UNII: 92005F972D)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
DMDM HYDANTOIN (UNII: BYR0546TOW)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
EDETATE SODIUM (UNII: MP1J8420LU)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:54162-250-04114 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart358H07/31/2015
Labeler - Geritrex LLC (112796248)

Revised: 1/2016
Document Id: 159e9ddd-d861-453b-8bf0-c2a0d603fd7c
Set id: 6f079fa9-2fa2-4988-ae1b-46b8fd670fac
Version: 1
Effective Time: 20160119
 
Geritrex LLC