Label: TERA-GEL- coal tar shampoo
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Contains inactivated NDC Code(s)
NDC Code(s): 54162-250-80 - Packager: Geritrex LLC
- Category: HUMAN OTC DRUG LABEL
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.
Drug Label Information
Updated January 19, 2016
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- Official Label (Printer Friendly)
- Active Ingredient
- Uses
- Directions
- DOSAGE & ADMINISTRATION
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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
- KEEP OUT OF REACH OF CHILDREN
- Inactive Ingredients:
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
TERA-GEL
coal tar shampooProduct 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 1.365 g in 237 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:54162-250-80 237 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)