Dosage and administration
Place enough product on hands to cover all surfaces. Rub hands together until dry. Supervise children under 6 years of age when using this product to avoid swallowing
Alcohol Antiseptic 80% Topical Solution Antiseptic Hand Rub
- Manufacturer
- Aurohealth LLC | Aurolife Pharma LLC
- Effective date
- 2020-06-25
- Label type
- Human OTC Drug Label
- Version
- 1
- Source
- full-release
- Hydrated at
- 2026-05-31 23:21:01
Label at a glance#
ProductAlcohol Antiseptic 80%
Active ingredientALCOHOL
Label structure13 sections
Storage and handling
Store between 15-30 o C (59-86 o F) Avoid freezing and excessive heat above 40 o C (104 o F)
Contacts and useful links#
Label contents#
Full prescribing information#
ACTIVE INGREDIENT(S)
Alcohol 80% v/v
PURPOSE
Antiseptic
USE(S)
Health care personnel hand rub to help reduce bacteria that potentially causes disease.
WARNINGS
For external use only. Flammable. Keep away from heat or flame.
DO NOT USE
- in children less than 2 months of age
- on open skin wounds
WHEN USING THIS PRODUCT
When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse thoroughly with water.
STOP USE AND ASK DOCTOR IF
Stop using and ask doctor if irritation or rash occurs. These may be signs of a serious condition.
KEEP OUT OF REACH OF CHILDREN
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
DIRECTIONS
- Place enough product on hands to cover all surfaces. Rub hands together until dry.
- Supervise children under 6 years of age when using this product to avoid swallowing
OTHER INFORMATION
- Store between 15-30oC (59-86oF)
- Avoid freezing and excessive heat above 40oC (104oF)
INACTIVE INGREDIENT SECTION
glycerin, hydrogen peroxide, purified water USP
QUESTIONS OR COMMENTS
Call 1-855-274-4122
PRINCIPAL DISPLAY PANEL
AUROHEALTH
NDC 58602-004-38
Alcohol Aniseptic 80%
Topical Solution
Antiseptic Hand Rub
Non-sterile Solution
128 OZ (3785 mL)
DailyMed RxNorm Mappings#
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 58602-004-38 | 2023-01-30 | C162847 | 48780-1 | f386c649-b57d-0266-e053-dadaa90a7c1a | Alcohol Antiseptic 80% Topical Solution Antiseptic Hand Rub |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 58602-004-38 | Alcohol Antiseptic 80% | 3785 mL in 1 BOTTLE | SOLUTION | 3785 | 1 |
DailyMed Dashboard NDC Coverage#
Products#
Every source-derived product name is available through these pages.
- Alcohol Antiseptic 80%
- ALCOHOL
- GLYCERIN
- HYDROGEN PEROXIDE
- WATER
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 58602-004 | 58602-004-38 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| ALCOHOL | 3K9958V90M | ACTIB |
| GLYCERIN | PDC6A3C0OX | IACT |
| HYDROGEN PEROXIDE | BBX060AN9V | IACT |
| WATER | 059QF0KO0R | IACT |
Source Document#
openFDA label cross-check#
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 |
|---|---|---|---|---|---|---|
| f19dea61-6d4a-463b-bbc6-2e7ca7c2759d | f19dea61-6d4a-463b-bbc6-2e7ca7c2759d | 2020-06-25 | Warnings | f19dea61-6d4a-463b-bbc6-2e7ca7c2759d f19dea61-6d4a-463b-bbc6-2e7ca7c2759d |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.