OTC - ACTIVE INGREDIENT SECTION
Active Ingredient
Ethyl Alcohol 63%
Active Ingredient
Ethyl Alcohol 63%
Purpose
Antiseptic
Uses
To decrease bacteria on the skin
For external use only.
When using this product: Keep out of eyes. Do not ingest.
Stop use and ask a doctor if skin irritation develops
Keep out of reach of children.
If swallowed, get medical assistance.
Directions
Other Information
Do not store above 105F
May discolor some fabrics
Inactive Ingredient:
Aqua, Carbomer, Triethanolamine, Parfum, Disodium EDTA, may contain D and C Red No. 33, FD and C Red No. 40, FD and C Blue No. 1, FD and C Yellow No. 5, FD and C Yellow No. 6.
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 50563-162-01 | 2019-11-27 | C162847 | 48780-1 | 9855e2a2-4e1b-60a7-e053-dbdaa90a05bd | Drug Fact |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 50563-162-01 | RUE 21 Fallen Vixen Anti Bacterial Hand Sanitizer | 29 mL in 1 BOTTLE | LIQUID | 29 | 1 |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| ALCOHOL | ACTIVE INGREDIENT | 3K9958V90M | 1 | |
| ALCOHOL | ACTIVE MOIETY | 3K9958V90M | 1 | |
| CARBOMER COPOLYMER TYPE A | INACTIVE INGREDIENT | 71DD5V995L | 1 | |
| D&C RED NO. 33 | INACTIVE INGREDIENT | 9DBA0SBB0L | 1 | |
| EDETATE DISODIUM | INACTIVE INGREDIENT | 7FLD91C86K | 1 | |
| FD&C BLUE NO. 1 | INACTIVE INGREDIENT | H3R47K3TBD | 1 | |
| FD&C RED NO. 40 | INACTIVE INGREDIENT | WZB9127XOA | 1 | |
| FD&C YELLOW NO. 5 | INACTIVE INGREDIENT | I753WB2F1M | 1 | |
| FD&C YELLOW NO. 6 | INACTIVE INGREDIENT | H77VEI93A8 | 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 |
|---|---|
| 50563-162 | 50563-162-01 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| ALCOHOL | 3K9958V90M | ACTIB |
| WATER | 059QF0KO0R | IACT |
| CARBOMER COPOLYMER TYPE A | 71DD5V995L | IACT |
| TROLAMINE | 9O3K93S3TK | IACT |
| EDETATE DISODIUM | 7FLD91C86K | IACT |
| D&C RED NO. 33 | 9DBA0SBB0L | IACT |
| FD&C BLUE NO. 1 | H3R47K3TBD | IACT |
| FD&C YELLOW NO. 5 | I753WB2F1M | IACT |
| FD&C YELLOW NO. 6 | H77VEI93A8 | IACT |
| FD&C RED NO. 40 | WZB9127XOA | 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 |
|---|---|---|---|---|---|---|
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | DROPS / AURICULAR (OTIC) | 0.05 %w/w | ||
| FD&C YELLOW NO. 5 | FD&C YELLOW NO. 5 | I753WB2F1M | POWDER / TOPICAL | NA | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | SYRUP / ORAL | 40 mg | ||
| FD&C YELLOW NO. 6 | FD&C YELLOW NO. 6 | H77VEI93A8 | POWDER / ORAL | 20 mg | ||
| CARBOMER COPOLYMER TYPE A | CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) | 71DD5V995L | LOTION / TOPICAL | 21 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | CAPSULE / ORAL | 5 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | SUSPENSION, EXTENDED RELEASE / ORAL | 40 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | MOUTHWASH / BUCCAL | NA | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | INJECTION, EMULSION / INTRAVENOUS | 59 mg | ||
| 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 | LIQUID / ORAL | NA | ||
| FD&C YELLOW NO. 6 | FD&C YELLOW NO. 6 | H77VEI93A8 | CAPSULE, COATED PELLETS / ORAL | NA | ||
| FD&C YELLOW NO. 6 | FD&C YELLOW NO. 6 | H77VEI93A8 | TABLET, EXTENDED RELEASE / ORAL | 8 mg | ||
| 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 / DENTAL | NA | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | INJECTION / INTRAVENOUS | 10 %w/v | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | SOLUTION / ORAL | 432 mg | ||
| FD&C YELLOW NO. 5 | FD&C YELLOW NO. 5 | I753WB2F1M | TABLET, COATED / ORAL | 7.93 mg | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | CAPSULE, COATED PELLETS / ORAL | NA | ||
| FD&C YELLOW NO. 5 | FD&C YELLOW NO. 5 | I753WB2F1M | SOLUTION / TOPICAL | 0.06 %w/w | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | ELIXIR / ORAL | NA | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | AEROSOL, FOAM / RECTAL | 2 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | FILM, SOLUBLE / ORAL | 0.04 mg | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | DROPS / ORAL | NA | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | SUSPENSION/ DROPS / OPHTHALMIC | 1 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | POWDER, FOR SUSPENSION / ORAL | 1 mg/5ml | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | SOLUTION / ORAL | 38 mg | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | ELIXIR / ORAL | 12.5 mg/5ml | ||
| FD&C YELLOW NO. 5 | FD&C YELLOW NO. 5 | I753WB2F1M | CAPSULE / ORAL | 652 mg | ||
| TROLAMINE | TROLAMINE | 9O3K93S3TK | GEL / TRANSDERMAL | 6 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | SPRAY / NASAL | 1 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | INJECTION / SOFT TISSUE | 0.05 %w/v | ||
| FD&C YELLOW NO. 6 | FD&C YELLOW NO. 6 | H77VEI93A8 | ELIXIR / ORAL | 5.4 mg/5ml | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | CAPSULE / ORAL | 26.3 mg | ||
| FD&C YELLOW NO. 6 | FD&C YELLOW NO. 6 | H77VEI93A8 | MOUTHWASH / BUCCAL | 0.01 mg/1ml | ||
| FD&C YELLOW NO. 6 | FD&C YELLOW NO. 6 | H77VEI93A8 | SUSPENSION, EXTENDED RELEASE / ORAL | 0.12 mg/5ml | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | TABLET, SUGAR COATED / ORAL | NA | ||
| 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 | SYRUP / ORAL | 0.1 mg | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | POWDER, FOR SUSPENSION / ORAL | 3 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | TABLET, FILM COATED / ORAL | 4 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | SUSPENSION/ DROPS / ORAL | 4 mg | ||
| FD&C YELLOW NO. 6 | FD&C YELLOW NO. 6 | H77VEI93A8 | SUSPENSION / ORAL | 11 mg | ||
| FD&C YELLOW NO. 6 | FD&C YELLOW NO. 6 | H77VEI93A8 | SOLUTION / RECTAL | 0.5 %w/v | ||
| TROLAMINE | TROLAMINE | 9O3K93S3TK | INJECTION, POWDER, FOR SUSPENSION / INTRAVENOUS | 0.02 %w/v | ||
| FD&C YELLOW NO. 5 | FD&C YELLOW NO. 5 | I753WB2F1M | OINTMENT / TOPICAL | 0.01 %w/w | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | GEL / VAGINAL | 5 mg | ||
| D&C RED NO. 33 | D&C RED NO. 33 | 9DBA0SBB0L | ELIXIR / ORAL | 27.5 mg/5ml | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | TABLET, DELAYED RELEASE / ORAL | 0.01 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | INJECTION / INTRAVASCULAR | 0.48 mg | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | CAPSULE / ORAL | 16 mg | ||
| TROLAMINE | TROLAMINE | 9O3K93S3TK | CREAM, AUGMENTED / TOPICAL | 20 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | LIQUID / ORAL | NA | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | SUSPENSION / ORAL | 30 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 | CONCENTRATE / ORAL | 0.02 mg/1ml | ||
| FD&C YELLOW NO. 5 | FD&C YELLOW NO. 5 | I753WB2F1M | SUPPOSITORY / VAGINAL | NA | ||
| D&C RED NO. 33 | D&C RED NO. 33 | 9DBA0SBB0L | CAPSULE, LIQUID FILLED / ORAL | 0.01 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | EMULSION / OPHTHALMIC | 0.3 %w/v | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | DROPS / OPHTHALMIC | 0.05 %w/v |
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 |
|---|---|---|---|---|---|---|
| 848a678c-ab24-48ee-b54e-a86468269025 | 52c986d5-107a-4353-8209-2a2e57eae47b | 2013-11-06 | Warnings | 848a678c-ab24-48ee-b54e-a86468269025 52c986d5-107a-4353-8209-2a2e57eae47b |
Adverse event summaries are temporarily unavailable. Other product information remains available.