Indications and uses
TO HELP PREVENT RECURRENCE OF FLAKING AND ITCHING ASSOCIATED WITH DANDRUFF
TO HELP PREVENT RECURRENCE OF FLAKING AND ITCHING ASSOCIATED WITH DANDRUFF
FOR MAXIMUM DANDRUFF CONTROL, USE EVERY TIME YOU SHAMPOO. WET HAIR, MASSAGE ONTO SCALP AND RINSE. REPEAT IF DESIRED
PYRITHIONE ZINC 1%
ANTI-DANDRUFF
TO HELP PREVENT RECURRENCE OF FLAKING AND ITCHING ASSOCIATED WITH DANDRUFF
FOR EXTERNAL USE ONLY
AVOID CONTACT WITH EYES. IF CONTACT OCCURS, RINSE EYES THOROUGHLY WITH WATER
CONDITION WORSENS OR DOES NOT IMPROVE AFTER REGULAR USE OF THIS PRODUCT AS DIRECTED
IN CASE OF ACCIDENTAL INGESTION, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY
FOR MAXIMUM DANDRUFF CONTROL, USE EVERY TIME YOU SHAMPOO. WET HAIR, MASSAGE ONTO SCALP AND RINSE. REPEAT IF DESIRED
WATER (AQUA), SODIUM LAURETH SULFATE, SODIUM LAURYL SULFATE, DIMETHICONE, COCAMIDE MEA, ZINC CARBONATE, GLYCOL DISTEARATE, SODIUM XYLENESULFONATE, FRAGRANCE (PARFUM), CETYL ALCOHOL, GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE, MAGNESIUM SULFATE, SODIUM CHLORIDE, SODIUM BENZOATE, MAGNESIUM CARBONATE HYDROXIDE, BENZYL ALCOHOL, PRUNUS AMYGDALUS DULCIS (SWEET ALMOND) OIL, CITRIC ACID, METHYLCHLOROISOTHIAZOLINONE, METHYISOTHIAZOLINONE, BLUE 1 (CI 42090), YELLOW 5 (CI 19140)
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 36800-333-14 | 2020-01-31 | C162847 | 48780-1 | 9d75b9cf-ef72-f424-e053-dadaa90a57ce | DRUG FACTS |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 36800-333-14 | TOPCAREGENTLE DANDRUFF GREEN APPLE | 420 mL in 1 BOTTLE, PLASTIC | LIQUID | 420 | 1 |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| PYRITHIONE ZINC | ACTIVE INGREDIENT | R953O2RHZ5 | 1 | |
| PYRITHIONE ZINC | ACTIVE MOIETY | R953O2RHZ5 | 1 | |
| ALMOND OIL | INACTIVE INGREDIENT | 66YXD4DKO9 | 1 | |
| BENZYL ALCOHOL | INACTIVE INGREDIENT | LKG8494WBH | 1 | |
| CETYL ALCOHOL | INACTIVE INGREDIENT | 936JST6JCN | 1 | |
| CITRIC ACID MONOHYDRATE | INACTIVE INGREDIENT | 2968PHW8QP | 1 | |
| COCO MONOETHANOLAMIDE | INACTIVE INGREDIENT | C80684146D | 1 | |
| DIMETHICONE | INACTIVE INGREDIENT | 92RU3N3Y1O | 1 | |
| FD&C BLUE NO. 1 | INACTIVE INGREDIENT | H3R47K3TBD | 1 | |
| FD&C YELLOW NO. 5 | INACTIVE INGREDIENT | I753WB2F1M | 1 | |
| GLYCOL DISTEARATE | INACTIVE INGREDIENT | 13W7MDN21W | 1 | |
| GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE) | INACTIVE INGREDIENT | B16G315W7A | 1 | |
| MAGNESIUM CARBONATE HYDROXIDE | INACTIVE INGREDIENT | YQO029V1L4 | 1 | |
| MAGNESIUM SULFATE | INACTIVE INGREDIENT | DE08037SAB | 1 | |
| METHYLCHLOROISOTHIAZOLINONE | INACTIVE INGREDIENT | DEL7T5QRPN | 1 | |
| METHYLISOTHIAZOLINONE | INACTIVE INGREDIENT | 229D0E1QFA | 1 | |
| SODIUM BENZOATE | INACTIVE INGREDIENT | OJ245FE5EU | 1 | |
| SODIUM CHLORIDE | INACTIVE INGREDIENT | 451W47IQ8X | 1 | |
| SODIUM LAURETH SULFATE | INACTIVE INGREDIENT | BPV390UAP0 | 1 | |
| SODIUM LAURYL SULFATE | INACTIVE INGREDIENT | 368GB5141J | 1 | |
| SODIUM XYLENESULFONATE | INACTIVE INGREDIENT | G4LZF950UR | 1 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | 1 | |
| ZINC CARBONATE | INACTIVE INGREDIENT | EQR32Y7H0M | 1 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 36800-333 | 36800-333-14 |
Every source-derived ingredient row is available through these pages.
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 |
|---|---|---|---|---|---|---|
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | INJECTION / INTRABURSAL | ADJ PH | ||
| SODIUM LAURYL SULFATE | SODIUM LAURYL SULFATE | 368GB5141J | SHAMPOO, SUSPENSION / TOPICAL | 40 %w/v | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | INJECTION, SOLUTION / INTRACAUDAL | 210 mg | ||
| BENZYL ALCOHOL | BENZYL ALCOHOL | LKG8494WBH | INJECTION / INTRA-ARTERIAL | 0.9 %w/v | ||
| MAGNESIUM SULFATE | MAGNESIUM SULFATE | DE08037SAB | TABLET, COATED / ORAL | NA | ||
| BENZYL ALCOHOL | BENZYL ALCOHOL | LKG8494WBH | INJECTION / INTRALESIONAL | 23 mg | ||
| BENZYL ALCOHOL | BENZYL ALCOHOL | LKG8494WBH | INJECTION, SOLUTION / SUBCUTANEOUS | 0.95 %w/v | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | SOLUTION / EPIDURAL | 0.9 %w/v | ||
| BENZYL ALCOHOL | BENZYL ALCOHOL | LKG8494WBH | INJECTION, SOLUTION / INTRAMUSCULAR | 500 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | INJECTION / INTRAVASCULAR | 0.86 %w/v | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | SYRUP / ORAL | 722 mg/5ml | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | CAPSULE, LIQUID FILLED / ORAL | 0.08 mg | ||
| SODIUM BENZOATE | SODIUM BENZOATE | OJ245FE5EU | GEL / RECTAL | 406 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | SOLUTION/ DROPS / TOPICAL | 0.86 %w/v | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | SUSPENSION / INTRATYMPANIC | 2 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | DOUCHE / VAGINAL | NA | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | SOLUTION / BUCCAL | NA | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | INJECTION / INTRAPLEURAL | ADJ PH | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | INJECTION / INTRATHECAL | ADJ PH | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | SOLUTION / RECTAL | 0.01 %w/v | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | LIQUID / ORAL | 114 mg | ||
| BENZYL ALCOHOL | BENZYL ALCOHOL | LKG8494WBH | SOLUTION / ORAL | 360 mg | ||
| SODIUM LAURYL SULFATE | SODIUM LAURYL SULFATE | 368GB5141J | TABLET, DELAYED RELEASE / ORAL | 199 mg | ||
| SODIUM LAURETH SULFATE | SODIUM LAURETH-3 SULFATE | BPV390UAP0 | SPRAY / TOPICAL | 0.1 %w/w | ||
| BENZYL ALCOHOL | BENZYL ALCOHOL | LKG8494WBH | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRACAVERNOUS | 18 mg | ||
| SODIUM LAURYL SULFATE | SODIUM LAURYL SULFATE | 368GB5141J | CREAM / VAGINAL | 12 mg | ||
| BENZYL ALCOHOL | BENZYL ALCOHOL | LKG8494WBH | CAPSULE / ORAL | 450 mg | ||
| SODIUM BENZOATE | SODIUM BENZOATE | OJ245FE5EU | SUSPENSION/ DROPS / ORAL | 23 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | CREAM / TOPICAL | 0.4 %w/w | ||
| FD&C YELLOW NO. 5 | FD&C YELLOW NO. 5 | I753WB2F1M | POWDER / TOPICAL | NA | ||
| SODIUM LAURYL SULFATE | SODIUM LAURYL SULFATE | 368GB5141J | TABLET, EFFERVESCENT / ORAL | 1.5 mg | ||
| BENZYL ALCOHOL | BENZYL ALCOHOL | LKG8494WBH | CREAM / VAGINAL | 1 %w/w | ||
| SODIUM BENZOATE | SODIUM BENZOATE | OJ245FE5EU | GRANULE, EFFERVESCENT / ORAL | 60 mg | ||
| SODIUM BENZOATE | SODIUM BENZOATE | OJ245FE5EU | INJECTION, SOLUTION / INTRAMUSCULAR | 4.8 %w/v | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | SOLUTION / IONTOPHORESIS | 0.02 %w/v | ||
| SODIUM LAURYL SULFATE | SODIUM LAURYL SULFATE | 368GB5141J | TABLET, EXTENDED RELEASE / ORAL | 320 mg | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | POWDER / ORAL | 840 mg | ||
| FD&C YELLOW NO. 5 | FD&C YELLOW NO. 5 | I753WB2F1M | OINTMENT / TOPICAL | 0.01 %w/w | ||
| SODIUM BENZOATE | SODIUM BENZOATE | OJ245FE5EU | PASTE / DENTAL | 0.08 %w/w | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | INJECTION / INTRALESIONAL | 0.9 %w/v | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | CREAM / TOPICAL | 4 mg | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | INJECTION / INTRACARDIAC | 1.05 %w/v | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | JELLY / NASAL | NA | ||
| BENZYL ALCOHOL | BENZYL ALCOHOL | LKG8494WBH | INJECTION, SOLUTION / INTRAVENOUS | 400 mg | ||
| FD&C YELLOW NO. 5 | FD&C YELLOW NO. 5 | I753WB2F1M | LOZENGE / BUCCAL | NA | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | SUSPENSION / AURICULAR (OTIC) | 0.9 %w/v | ||
| FD&C YELLOW NO. 5 | FD&C YELLOW NO. 5 | I753WB2F1M | TABLET / ORAL | 180 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | INJECTION, SOLUTION / INTRA-ARTERIAL | 278 mg | ||
| SODIUM LAURYL SULFATE | SODIUM LAURYL SULFATE | 368GB5141J | CAPSULE / RESPIRATORY (INHALATION) | NA | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | SOLUTION / INTRAPERITONEAL | 0.54 %w/v | ||
| BENZYL ALCOHOL | BENZYL ALCOHOL | LKG8494WBH | LOTION / TOPICAL | 4000 mg | ||
| BENZYL ALCOHOL | BENZYL ALCOHOL | LKG8494WBH | SUSPENSION / AURICULAR (OTIC) | 0.9 %w/v | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | INJECTION / INTRAMUSCULAR | 1486 mg | ||
| FD&C YELLOW NO. 5 | FD&C YELLOW NO. 5 | I753WB2F1M | TABLET, SUGAR COATED / ORAL | NA | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | INJECTION, POWDER, FOR SOLUTION / INTRAPLEURAL | 226 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | INJECTION / ENDOTRACHEAL | 68 mg | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | INHALANT / RESPIRATORY (INHALATION) | NA | ||
| CETYL ALCOHOL | CETYL ALCOHOL | 936JST6JCN | CREAM / TOPICAL | 1280 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | INJECTION / INTRA-ARTICULAR | 26 mg | ||
| CETYL ALCOHOL | CETYL ALCOHOL | 936JST6JCN | TABLET, FILM COATED, EXTENDED RELEASE / ORAL | 59 mg |
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 |
|---|---|---|---|---|---|---|
| 3ec63c53-688a-4968-adb0-0bbee8dd243f | 86889cb2-1f70-4876-a3e2-6821c00f9419 | 2014-07-28 | Warnings | 3ec63c53-688a-4968-adb0-0bbee8dd243f 86889cb2-1f70-4876-a3e2-6821c00f9419 |
Adverse event summaries are temporarily unavailable. Other product information remains available.