OTC - ACTIVE INGREDIENT SECTION
Active Ingredient
Solubilized Coal Tar Extract 2.5% (Coal Tar 0.5%)
OTC - PURPOSE SECTION
Purpose
Anti-Dandruff
Active Ingredient
Solubilized Coal Tar Extract 2.5% (Coal Tar 0.5%)
Purpose
Anti-Dandruff
Use controls the symptoms of: •dandruff •seborrheic dermatitis •psoriasis
Warnings
For external use only!
Ask a doctor before use if you have a condition which covers a large part of the body
When using this product
•do not get into eyes. If contact occurs, rinse eyes thoroughly with water.
•use caution in exposing skin to sunlight after applying this product. It may increase your tendency to sunburn for up to 24 hours after application
•do not use for prolonged periods without consulting a doctor
•do not use with other forms of psoriasis therapy such as ultraviolet radiation or prescription drugs unless directed to do so by a doctor.
Stop use and ask a doctor if condition worsens or does not improve
after regular use of this product as directed.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Directions
•wet hair thoroughly
•massage shampoo into scalp
•lather. Leave on hair and scalp for several minutes
•rinse and repeat
•for best results use at least twice a week or as directed by a doctor
Other information
•store away from direct sunlight
•in rare instances, discoloration of gray, blonde, bleached, or tinted hair may occur
Inactive ingredients water, sodium laureth sulfate, Cocamidopropylamine oxide, laureth-4, ccocamidopropyl betaine, fragrance, sodium chloride, citric acid, DMDM Hydantoin, tetrasodium EDTA, PEG-150 distearate, caramel, FD+C red #33
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 58180-201-01 | 2020-04-05 | C162847 | 48780-1 | 9d75b9d0-fa78-f424-e053-dadaa90a57ce | Drug Facts |
| 58180-201-01 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-fa78-f424-e053-dadaa90a57ce | Drug Facts |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| COAL TAR | ACTIVE INGREDIENT | R533ESO2EC | 1 | |
| COAL TAR | ACTIVE MOIETY | R533ESO2EC | 1 | |
| CARAMEL | INACTIVE INGREDIENT | T9D99G2B1R | 1 | |
| CITRIC ACID MONOHYDRATE | INACTIVE INGREDIENT | 2968PHW8QP | 1 | |
| COCAMIDOPROPYL BETAINE | INACTIVE INGREDIENT | 5OCF3O11KX | 1 | |
| COCAMIDOPROPYLAMINE OXIDE | INACTIVE INGREDIENT | M4SL82J7HK | 1 | |
| D&C RED NO. 33 | INACTIVE INGREDIENT | 9DBA0SBB0L | 1 | |
| DMDM HYDANTOIN | INACTIVE INGREDIENT | BYR0546TOW | 1 | |
| EDETATE SODIUM | INACTIVE INGREDIENT | MP1J8420LU | 1 | |
| LAURETH-4 | INACTIVE INGREDIENT | 6HQ855798J | 1 | |
| PEG-150 DISTEARATE | INACTIVE INGREDIENT | 6F36Q0I0AC | 1 | |
| SODIUM CHLORIDE | INACTIVE INGREDIENT | 451W47IQ8X | 1 | |
| SODIUM LAURETH SULFATE | INACTIVE INGREDIENT | BPV390UAP0 | 1 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | 1 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 58180-201 | 58180-201-01 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| COAL TAR | R533ESO2EC | ACTIB |
| WATER | 059QF0KO0R | IACT |
| SODIUM LAURETH SULFATE | BPV390UAP0 | IACT |
| COCAMIDOPROPYLAMINE OXIDE | M4SL82J7HK | IACT |
| LAURETH-4 | 6HQ855798J | IACT |
| COCAMIDOPROPYL BETAINE | 5OCF3O11KX | IACT |
| SODIUM CHLORIDE | 451W47IQ8X | IACT |
| CITRIC ACID MONOHYDRATE | 2968PHW8QP | IACT |
| DMDM HYDANTOIN | BYR0546TOW | IACT |
| EDETATE SODIUM | MP1J8420LU | IACT |
| PEG-150 DISTEARATE | 6F36Q0I0AC | IACT |
| CARAMEL | T9D99G2B1R | IACT |
| D&C RED NO. 33 | 9DBA0SBB0L | IACT |
Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | INJECTION, POWDER, FOR SOLUTION / INTRAPERITONEAL | 226 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | LIQUID / INTRAVENOUS | 6320 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | INJECTION / EPIDURAL | 648 mg | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | GEL / TOPICAL | 1 mg | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | SOLUTION / IONTOPHORESIS | 0.02 %w/v | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | INJECTION, SOLUTION / INTRATHECAL | 131 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | DROPS / OPHTHALMIC | 0.08 %w/w | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | INHALANT / RESPIRATORY (INHALATION) | NA | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | SOLUTION / ORAL | 446 mg | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS | 608 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | INJECTION, POWDER, FOR SOLUTION / INTRAPLEURAL | 226 mg | ||
| CARAMEL | CARAMEL | T9D99G2B1R | CREAM / TOPICAL | 0.26 %w/w | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | SOLUTION / OPHTHALMIC | 0.03 %w/v | ||
| EDETATE SODIUM | EDETATE SODIUM | MP1J8420LU | INJECTION / INTRAVENOUS | 0.01 %w/v | ||
| LAURETH-4 | LAURETH-4 | 6HQ855798J | CREAM / TOPICAL | 1.1 %w/w | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | SOLUTION / INTRAMUSCULAR | 0.05 %w/v | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | POWDER, FOR SOLUTION / TOPICAL | NA | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | INJECTION, SOLUTION, CONCENTRATE / IRRIGATION | 1 mg | ||
| CARAMEL | CARAMEL | T9D99G2B1R | GRANULE, FOR SUSPENSION / ORAL | 2.5 mg/5ml | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | INJECTION / INTRATHECAL | 9 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | SOLUTION / INTRAVASCULAR | NA | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | SYSTEM / TOPICAL | 0.2 mg | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | SOLUTION / AURICULAR (OTIC) | 0.2 %w/v | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | INJECTION / INTRALESIONAL | 0.9 %w/v | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | TABLET, CHEWABLE / ORAL | 20 mg | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | SOAP / TOPICAL | 0.5 %w/w | ||
| D&C RED NO. 33 | D&C RED NO. 33 | 9DBA0SBB0L | SOLUTION / ORAL | 2 mg | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL | 2 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | TABLET, COATED / ORAL | 54.7 mg | ||
| LAURETH-4 | LAURETH-4 | 6HQ855798J | LOTION / TOPICAL | 1.3 %w/w | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAMUSCULAR | 360 mg | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | TABLET, CHEWABLE / ORAL | 7 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | INJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR | 226 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | INJECTION, SOLUTION / INTRAVESICAL | 351 mg | ||
| CARAMEL | CARAMEL | T9D99G2B1R | SUSPENSION / ORAL | 111.12 mg/5ml | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | SOLUTION / RESPIRATORY (INHALATION) | 108 mg | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | INJECTION, SOLUTION / INTRA-ARTICULAR | ADJ PH | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | CREAM / VAGINAL | 0.49 %w/w | ||
| SODIUM LAURETH SULFATE | SODIUM LAURETH-3 SULFATE | BPV390UAP0 | SHAMPOO / TOPICAL | 3192 mg | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | DOUCHE / VAGINAL | 0.07 %w/w | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | INJECTION, SOLUTION, CONCENTRATE / INTRAOCULAR | 0.86 %w/v | ||
| D&C RED NO. 33 | D&C RED NO. 33 | 9DBA0SBB0L | ELIXIR / ORAL | 27.5 mg/5ml | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | TABLET / SUBLINGUAL | 24 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | SOLUTION / AURICULAR (OTIC) | 18 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | INJECTION / INTRACAVITARY | 0.82 %w/v | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | SOLUTION/ DROPS / OPHTHALMIC | 55 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | LIQUID / SUBCUTANEOUS | 0.7 %w/v | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | FILM, EXTENDED RELEASE / TRANSDERMAL | 1.38 mg | ||
| EDETATE SODIUM | EDETATE SODIUM | MP1J8420LU | INJECTION, SOLUTION / INTRAVENOUS | 0.04 %w/v | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | INJECTION / SUBCUTANEOUS | 1486 mg | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | CAPSULE / ORAL | 238 mg | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | SPRAY, METERED / NASAL | 2 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | TABLET / ORAL | 231 mg | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | INJECTION, SOLUTION, CONCENTRATE / INTRAOCULAR | 1 mg | ||
| CARAMEL | CARAMEL | T9D99G2B1R | SOLUTION / RECTAL | NA | ||
| D&C RED NO. 33 | D&C RED NO. 33 | 9DBA0SBB0L | SHAMPOO / TOPICAL | NA | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | AEROSOL, FOAM / RECTAL | 7 mg | ||
| LAURETH-4 | LAURETH-4 | 6HQ855798J | SOLUTION / TOPICAL | 5.22 %w/v | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | INJECTION / INFILTRATION | 648 mg | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | INJECTION / INTRALESIONAL | ADJ PH |
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| d88becc1-5fda-4fd4-9de7-396d93b7d2c5 | 9dd49ccd-11d2-4297-a4ba-94db61858d7c | 2020-04-06 | Warnings | 9dd49ccd-11d2-4297-a4ba-94db61858d7c |
Adverse event summaries are temporarily unavailable. Other product information remains available.