OTC - ACTIVE INGREDIENT SECTION
Active Ingredient Purpose
Ethanol 80% w/w.......................Antiseptic
Active Ingredient Purpose
Ethanol 80% w/w.......................Antiseptic
Uses
surgical hand antiseptic
significantly reduces the number of micro-organisms on the hands and forearms prior to surgery or patient care
Warnings
For external use only.
Flammable, keep away from fire or flame.
Do not use in or near eyes or on mucous membranes.
When using this product and contact with eyes occurs, flush immediately with water.
Stop use and ask a doctor if
irritation and redness develop
conditions persists for more than 72 hours
Keep out of reach of children.
If swallowed, get medical help or contact a Poison Control Center right away.
Directions
apply to clean dry hands
for the first use of the day, use a nail pick
dispense approx. 2 mL into hand, dip fingers of opposite hand into palm, working product under nails and into cuticles
repeat procedure with other hand
with hands still moist spread around the hand and lower 1/3 of the forearm
reapply the product to the hands, paying particular attention to fingers, cuticles, and interdigital spaces
following application, rub hands until dry
hands should remain moist for entire application time, approx. 2 minutes
Inactive Ingredients
Ethylhexyl Ethylhexanoate, Fragrance, Isohexadecane, Lanolin Alcohol, Myristyl Alcohol, PCA, Sodium PCA, Water.
Sterillium Rub
Procedural Scrub
Surgical Hand Antiseptic
80% ethyl alcohol w/w with emollients
Indication: Significantly reduces the number of micro-organisms on the hands andforearms prior to surgery or patient care.
Fast-acting.
Dermatologically tested.
Gentle to skin.
Read Drug Facts panel before use.
Lot:
Use by:
Questions? Call 1-800-MEDLINE, 7 a.m.-7 p.m. CST
1000 mL 33.8 fl. oz.
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 65616-001-01 | 2019-11-06 | C162847 | 48780-1 | 956f9ecf-ca44-621f-e053-dbdaa90a74ad | Drug Facts |
| 65616-001-06 | 2019-11-06 | C162847 | 48780-1 | 956f9ecf-ca44-621f-e053-dbdaa90a74ad | Drug Facts |
| 65616-001-08 | 2019-11-06 | C162847 | 48780-1 | 956f9ecf-ca44-621f-e053-dbdaa90a74ad | Drug Facts |
| 65616-001-01 | 2019-10-21 | C162847 | 48780-1 | 956f9ecf-ca44-621f-e053-dbdaa90a74ad | Drug Facts |
| 65616-001-06 | 2019-10-21 | C162847 | 48780-1 | 956f9ecf-ca44-621f-e053-dbdaa90a74ad | Drug Facts |
| 65616-001-08 | 2019-10-21 | C162847 | 48780-1 | 956f9ecf-ca44-621f-e053-dbdaa90a74ad | Drug Facts |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| Alcohol | ACTIVE INGREDIENT | 3K9958V90M | 1 | |
| Alcohol | ACTIVE MOIETY | 3K9958V90M | 1 | |
| Myristyl Alcohol | INACTIVE INGREDIENT | V42034O9PU | 1 | |
| Water | INACTIVE INGREDIENT | 059QF0KO0R | 1 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 65616-001 | 65616-001-01, 65616-001-06, 65616-001-08 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| Alcohol | 3K9958V90M | ACTIB |
| Myristyl Alcohol | V42034O9PU | IACT |
| Water | 059QF0KO0R | 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 |
|---|---|---|---|---|---|---|
| Myristyl Alcohol | MYRISTYL ALCOHOL | V42034O9PU | SUSPENSION / TOPICAL | 1.05 %w/w | ||
| Myristyl Alcohol | MYRISTYL ALCOHOL | V42034O9PU | TABLET, EXTENDED RELEASE / ORAL | 2 mg | ||
| Myristyl Alcohol | MYRISTYL ALCOHOL | V42034O9PU | CREAM / TOPICAL | 3 %w/w | ||
| Myristyl Alcohol | MYRISTYL ALCOHOL | V42034O9PU | AEROSOL, FOAM / TOPICAL | 2.5 %w/w |
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 |
|---|---|---|---|---|---|---|
| 96b2fe5d-8fc6-57c3-e053-2995a90adca2 | e72c445c-df04-4d37-bd33-f495a3688104 | 2019-11-06 | Warnings | e72c445c-df04-4d37-bd33-f495a3688104 |
Adverse event summaries are temporarily unavailable. Other product information remains available.