TERA-GEL- coal tar shampoo

Tera-Gel by

Drug Labeling and Warnings

Tera-Gel by is a Otc medication manufactured, distributed, or labeled by Geritrex LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

DOSAGE & ADMINISTRATION

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.

STORAGE AND HANDLING

15°-30°C (59°-86°F).

KEEP OUT OF REACH OF CHILDREN

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

TERA-GEL 
coal tar shampoo

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54162-250
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
COAL TAR (UNII: R533ESO2EC) (COAL TAR - UNII:R533ESO2EC)	COAL TAR	0.57 g  in 114 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54162-250-04	114 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part358H	07/31/2015

Labeler - Geritrex LLC (112796248)