INACTIVE INGREDIENT SECTION
Inactive Ingredients
Water, Acrylates/C10-30 Alkyl Acrylate Crosspolymer,
Triethonalamine, Fragrance, PEG-40 Hydrogenated
Castor Oil, May contain:
D C Red 33, FD C Red 4, FD C Yellow 5, FD C Blue 1
Inactive Ingredients
Water, Acrylates/C10-30 Alkyl Acrylate Crosspolymer,
Triethonalamine, Fragrance, PEG-40 Hydrogenated
Castor Oil, May contain:
D C Red 33, FD C Red 4, FD C Yellow 5, FD C Blue 1
Active Ingredient
Alcohol Denat 62 % w/w
Purpose
Antibacterial
Use
-To decrease bacteria on the skin and clean hands
-Recommended for repeated use
Warnings
For external use only
Keep out of reach of children.
If accidentally swallowed, get medical help or
contact a Poison Control Center right away.
Discontinue use if irritation or redness develop. If irritation persists
for more than 72 hours, consult a doctor.
Do not get into eye. If contact occurs, rinse thoroughly with water.
Directions - Apply to hands until thoroughly wet - Rub
vigorously until dry.
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 56136-001-01 | 2019-11-27 | C162847 | 48780-1 | 9855d018-d934-cd31-e053-dbdaa90ab51a | Drug Facts |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 56136-001-01 | Spatheraphy | 30 mL in 1 BOTTLE | LOTION | 30 | 1 |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| ALCOHOL | ACTIVE INGREDIENT | 3K9958V90M | 1 | |
| ALCOHOL | ACTIVE MOIETY | 3K9958V90M | 1 | |
| CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) | INACTIVE INGREDIENT | 71DD5V995L | 1 | |
| CASTOR OIL | INACTIVE INGREDIENT | D5340Y2I9G | 1 | |
| D&C RED NO. 33 | INACTIVE INGREDIENT | 9DBA0SBB0L | 1 | |
| FD&C BLUE NO. 1 | INACTIVE INGREDIENT | H3R47K3TBD | 1 | |
| FD&C RED NO. 4 | INACTIVE INGREDIENT | X3W0AM1JLX | 1 | |
| FD&C YELLOW NO. 5 | INACTIVE INGREDIENT | I753WB2F1M | 1 | |
| POLYETHYLENE GLYCOL 2000 | INACTIVE INGREDIENT | HAF0412YIT | 1 | |
| TROLAMINE | INACTIVE INGREDIENT | 9O3K93S3TK | 1 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | 1 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 56136-001 | 56136-001-01 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| ALCOHOL | 3K9958V90M | ACTIB |
| WATER | 059QF0KO0R | IACT |
| CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) | 71DD5V995L | IACT |
| TROLAMINE | 9O3K93S3TK | IACT |
| POLYETHYLENE GLYCOL 2000 | HAF0412YIT | IACT |
| CASTOR OIL | D5340Y2I9G | IACT |
| D&C RED NO. 33 | 9DBA0SBB0L | IACT |
| FD&C RED NO. 4 | X3W0AM1JLX | IACT |
| FD&C YELLOW NO. 5 | I753WB2F1M | IACT |
| FD&C BLUE NO. 1 | H3R47K3TBD | 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 |
|---|---|---|---|---|---|---|
| D&C RED NO. 33 | D&C RED NO. 33 | 9DBA0SBB0L | SOLUTION / ORAL | 2 mg | ||
| CASTOR OIL | CASTOR OIL | D5340Y2I9G | TABLET / SUBLINGUAL | 1.6 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | TABLET, EXTENDED RELEASE / ORAL | 4 mg | ||
| FD&C YELLOW NO. 5 | FD&C YELLOW NO. 5 | I753WB2F1M | POWDER / TOPICAL | NA | ||
| TROLAMINE | TROLAMINE | 9O3K93S3TK | LOTION / TOPICAL | 360 mg | ||
| CASTOR OIL | CASTOR OIL | D5340Y2I9G | TABLET, EXTENDED RELEASE / ORAL | 23.27 mg | ||
| TROLAMINE | TROLAMINE | 9O3K93S3TK | SPONGE / TOPICAL | 11 %w/w | ||
| CASTOR OIL | CASTOR OIL | D5340Y2I9G | TABLET / ORAL | 17 mg | ||
| FD&C YELLOW NO. 5 | FD&C YELLOW NO. 5 | I753WB2F1M | LOZENGE / BUCCAL | NA | ||
| TROLAMINE | TROLAMINE | 9O3K93S3TK | AEROSOL, METERED / RECTAL | ADJ PH | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | CAPSULE, EXTENDED RELEASE / ORAL | 1 mg | ||
| TROLAMINE | TROLAMINE | 9O3K93S3TK | GEL / TOPICAL | 6 mg | ||
| D&C RED NO. 33 | D&C RED NO. 33 | 9DBA0SBB0L | CONCENTRATE / ORAL | 0.02 mg/1ml | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | PASTE / DENTAL | NA | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | LIQUID / TOPICAL | NA | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | TABLET / ORAL | 27.53 mg | ||
| D&C RED NO. 33 | D&C RED NO. 33 | 9DBA0SBB0L | SHAMPOO / TOPICAL | NA | ||
| FD&C YELLOW NO. 5 | FD&C YELLOW NO. 5 | I753WB2F1M | LIQUID / ORAL | NA | ||
| FD&C YELLOW NO. 5 | FD&C YELLOW NO. 5 | I753WB2F1M | SUPPOSITORY / VAGINAL | NA | ||
| FD&C YELLOW NO. 5 | FD&C YELLOW NO. 5 | I753WB2F1M | SOLUTION / ORAL | 1 mg/1ml | ||
| D&C RED NO. 33 | D&C RED NO. 33 | 9DBA0SBB0L | TABLET, COATED / ORAL | NA | ||
| TROLAMINE | TROLAMINE | 9O3K93S3TK | AEROSOL, FOAM / VAGINAL | 2 %w/w | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | TABLET, COATED / ORAL | 0.52 mg | ||
| TROLAMINE | TROLAMINE | 9O3K93S3TK | CREAM / VAGINAL | 56 mg | ||
| TROLAMINE | TROLAMINE | 9O3K93S3TK | LIQUID / TOPICAL | NA | ||
| FD&C YELLOW NO. 5 | FD&C YELLOW NO. 5 | I753WB2F1M | OINTMENT / TOPICAL | 0.01 %w/w | ||
| TROLAMINE | TROLAMINE | 9O3K93S3TK | SOAP / TOPICAL | 0.08 %w/w | ||
| D&C RED NO. 33 | D&C RED NO. 33 | 9DBA0SBB0L | SYRUP / ORAL | 1 mg | ||
| CASTOR OIL | CASTOR OIL | D5340Y2I9G | TABLET, COATED / ORAL | 0.9 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | CONCENTRATE / ORAL | NA | ||
| D&C RED NO. 33 | D&C RED NO. 33 | 9DBA0SBB0L | CAPSULE / ORAL | 1 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | CAPSULE, DELAYED RELEASE / ORAL | 2 mg | ||
| FD&C YELLOW NO. 5 | FD&C YELLOW NO. 5 | I753WB2F1M | CONCENTRATE / BUCCAL | NA | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | TABLET, SUGAR COATED / ORAL | NA | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | MOUTHWASH / BUCCAL | NA | ||
| D&C RED NO. 33 | D&C RED NO. 33 | 9DBA0SBB0L | ELIXIR / ORAL | 27.5 mg/5ml | ||
| TROLAMINE | TROLAMINE | 9O3K93S3TK | INJECTION, POWDER, FOR SUSPENSION / INTRAVENOUS | 0.02 %w/v | ||
| CASTOR OIL | CASTOR OIL | D5340Y2I9G | INJECTION / INTRAMUSCULAR | 885 mg | ||
| TROLAMINE | TROLAMINE | 9O3K93S3TK | DROPS / NASAL | NA | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | CONCENTRATE / BUCCAL | NA | ||
| TROLAMINE | TROLAMINE | 9O3K93S3TK | GEL, METERED / TRANSDERMAL | 14 mg | ||
| CASTOR OIL | CASTOR OIL | D5340Y2I9G | GEL / NASAL | 429 mg | ||
| CASTOR OIL | CASTOR OIL | D5340Y2I9G | CAPSULE / ORAL | 1.04 mg | ||
| D&C RED NO. 33 | D&C RED NO. 33 | 9DBA0SBB0L | SUSPENSION / ORAL | 0.13 mg/5ml | ||
| CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) | CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) | 71DD5V995L | LOTION / TOPICAL | 21 mg | ||
| CASTOR OIL | CASTOR OIL | D5340Y2I9G | INJECTION, SOLUTION / INTRAMUSCULAR | 525 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | SOLUTION / ORAL | 1.13 mg/15ml | ||
| CASTOR OIL | CASTOR OIL | D5340Y2I9G | CAPSULE, EXTENDED RELEASE / ORAL | 47 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | POWDER, FOR SUSPENSION / ORAL | 1 mg/5ml | ||
| FD&C YELLOW NO. 5 | FD&C YELLOW NO. 5 | I753WB2F1M | SYRUP / ORAL | 0.1 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | PASTE, DENTIFRICE / DENTAL | NA | ||
| TROLAMINE | TROLAMINE | 9O3K93S3TK | SOLUTION / TOPICAL | NA | ||
| D&C RED NO. 33 | D&C RED NO. 33 | 9DBA0SBB0L | CAPSULE, LIQUID FILLED / ORAL | 0.01 mg | ||
| CASTOR OIL | CASTOR OIL | D5340Y2I9G | TABLET, DELAYED RELEASE / ORAL | 0.01 mg | ||
| TROLAMINE | TROLAMINE | 9O3K93S3TK | CREAM / TOPICAL | 1 %w/w | ||
| D&C RED NO. 33 | D&C RED NO. 33 | 9DBA0SBB0L | SUSPENSION, EXTENDED RELEASE / ORAL | NA | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | SOLUTION / TOPICAL | 0.01 %w/w | ||
| FD&C YELLOW NO. 5 | FD&C YELLOW NO. 5 | I753WB2F1M | TABLET, FILM COATED / ORAL | 1.68 mg | ||
| FD&C YELLOW NO. 5 | FD&C YELLOW NO. 5 | I753WB2F1M | ELIXIR / ORAL | 0.15 mg | ||
| FD&C YELLOW NO. 5 | FD&C YELLOW NO. 5 | I753WB2F1M | TABLET, DELAYED RELEASE / ORAL | 3 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 |
|---|---|---|---|---|---|---|
| 69db839e-cb3a-43fd-8bea-5a1785ff900e | b01981e3-b1bf-4584-bbef-11b93023f2d4 | 2013-08-06 | Warnings | 69db839e-cb3a-43fd-8bea-5a1785ff900e b01981e3-b1bf-4584-bbef-11b93023f2d4 |
Adverse event summaries are temporarily unavailable. Other product information remains available.