Label: MEDICASP ANTI-DANDRUFF- coal tar shampoo
- NDC Code(s): 50066-054-01
- Packager: Genomma Lab USA Inc.
- 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 December 11, 2018
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient
- Purpose
- Use
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Warnings
For external use only
When using this product
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- do not get into the eyes. If contact occurs, rinse eyes thoroughly with water
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- use caution exposing skin to sunlight after applying this product. It may increase your tendency to sunburn for up to 24 hours after application.
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- do not use for prolonged periods without consulting a doctor
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- do not use with other forms of psoriasis therapy such as ultra violet radiation or prescription drugs unless directed to do so by a doctor.
- Directions
- Other information
- Inactive ingredients
- Questions or comments?
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 177 ml Bottle Carton
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INGREDIENTS AND APPEARANCE
MEDICASP ANTI-DANDRUFF
coal tar shampooProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50066-054 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Coal Tar (UNII: R533ESO2EC) (Coal Tar - UNII:R533ESO2EC) Coal Tar 5 mg in 1 mL Inactive Ingredients Ingredient Name Strength Water (UNII: 059QF0KO0R) Sodium Laureth-3 Sulfate (UNII: BPV390UAP0) COCO Monoethanolamide (UNII: C80684146D) Cocamidopropyl Betaine (UNII: 5OCF3O11KX) Laureth-4 (UNII: 6HQ855798J) Polysorbate 20 (UNII: 7T1F30V5YH) Citric Acid Monohydrate (UNII: 2968PHW8QP) Sodium Chloride (UNII: 451W47IQ8X) Edetate Sodium (UNII: MP1J8420LU) DMDM Hydantoin (UNII: BYR0546TOW) Caramel (UNII: T9D99G2B1R) FD&C Red No. 40 (UNII: WZB9127XOA) Product Characteristics Color BROWN Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50066-054-01 1 in 1 CARTON 09/16/2013 1 177 mL in 1 BOTTLE, DISPENSING; 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 09/16/2013 Labeler - Genomma Lab USA Inc. (832323534) Establishment Name Address ID/FEI Business Operations Garcoa, Inc. 036464697 MANUFACTURE(50066-054)