OTC - ACTIVE INGREDIENT SECTION
Active ingredient Purpose
Benzethonium Chloride 0.1 %......................................................Antiseptic
Warnings
For external use only.
When using this product • Do not get into eyes. • If contact occurs, rinse eyes thoroughly with water. Stop use and ask doctor if • if skin irritation and redness develop.
Keep this and all drugs out of the reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 76077-100-04 | 2019-11-13 | C162847 | 48780-1 | 97449f38-be9d-f6ea-e053-dbdaa90aa703 | Drug Facts |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 76077-100-04 | Novana Wash Perineal Skin Cleanser | 120 mL in 1 BOTTLE, SPRAY | SOLUTION | 120 | 3 |
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 76077-100-04 | ML - Milliliter | 76077-100 | ccff3c47-0479-4e8e-9abe-8c03bfdc282e | 1 | 2013-02-13 |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| Benzethonium Chloride | ACTIVE INGREDIENT | PH41D05744 | 3 | |
| Benzethonium | ACTIVE MOIETY | 1VU15B70BP | 3 | |
| Iodopropynyl Butylcarbamate | INACTIVE INGREDIENT | 603P14DHEB | 3 | |
| Phenoxyethanol | INACTIVE INGREDIENT | HIE492ZZ3T | 3 | |
| POLYQUATERNIUM-7 (76/24 ACRYLAMIDE/DADMAC; 120 KD) | INACTIVE INGREDIENT | AAJ238UT03 | 3 | |
| Sodium Laureth Sulfate | INACTIVE INGREDIENT | BPV390UAP0 | 3 | |
| Water | INACTIVE INGREDIENT | 059QF0KO0R | 3 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 76077-100 | 76077-100-04 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| Benzethonium Chloride | PH41D05744 | ACTIB |
| Water | 059QF0KO0R | IACT |
| Sodium Laureth Sulfate | BPV390UAP0 | IACT |
| POLYQUATERNIUM-7 (76/24 ACRYLAMIDE/DADMAC; 120 KD) | AAJ238UT03 | IACT |
| Phenoxyethanol | HIE492ZZ3T | IACT |
| Iodopropynyl Butylcarbamate | 603P14DHEB | 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 |
|---|---|---|---|---|---|---|
| Phenoxyethanol | PHENOXYETHANOL | HIE492ZZ3T | GEL / TOPICAL | 14 mg | ||
| Phenoxyethanol | PHENOXYETHANOL | HIE492ZZ3T | LOTION / TOPICAL | 1 %w/w | ||
| Sodium Laureth Sulfate | SODIUM LAURETH-3 SULFATE | BPV390UAP0 | TABLET / ORAL | 0.91 mg | ||
| Sodium Laureth Sulfate | SODIUM LAURETH-3 SULFATE | BPV390UAP0 | SHAMPOO / TOPICAL | 3192 mg | ||
| Phenoxyethanol | PHENOXYETHANOL | HIE492ZZ3T | AEROSOL / TOPICAL | 1.05 %w/w | ||
| Phenoxyethanol | PHENOXYETHANOL | HIE492ZZ3T | AEROSOL, FOAM / TOPICAL | 72 mg | ||
| Phenoxyethanol | PHENOXYETHANOL | HIE492ZZ3T | CREAM, AUGMENTED / TOPICAL | 10 mg | ||
| Phenoxyethanol | PHENOXYETHANOL | HIE492ZZ3T | CREAM / TOPICAL | 57 mg | ||
| Sodium Laureth Sulfate | SODIUM LAURETH-3 SULFATE | BPV390UAP0 | CAPSULE / ORAL | 3.5 mg | ||
| Sodium Laureth Sulfate | SODIUM LAURETH-3 SULFATE | BPV390UAP0 | SPRAY / TOPICAL | 0.1 %w/w | ||
| Sodium Laureth Sulfate | SODIUM LAURETH-3 SULFATE | BPV390UAP0 | CREAM / TOPICAL | NA |
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 |
|---|---|---|---|---|---|---|
| 7889c1e5-b6bf-4e8f-bb70-a4f73ca9bbcc | 26fc597d-d98e-4334-8bfc-f6543083b5b7 | 2012-04-04 | Warnings | 7889c1e5-b6bf-4e8f-bb70-a4f73ca9bbcc 26fc597d-d98e-4334-8bfc-f6543083b5b7 |
Adverse event summaries are temporarily unavailable. Other product information remains available.