OTC - ACTIVE INGREDIENT SECTION
Active Ingredients:
Povidone-iodine USP 10% w/v
ALPHA ONE
- Manufacturer
- AOSS Medical Supply, Inc.
- Effective date
- 2019-10-23
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- full-release
- Hydrated at
- 2026-05-31 23:01:20
Label at a glance#
ProductALPHA ONE
Active ingredientPOVIDONE-IODINE
Label structure11 sections
Label contents#
Full prescribing information#
OTC - PURPOSE SECTION
Purpose
Antiseptic
INDICATIONS & USAGE SECTION
Uses
- Health care antiseptic for preparation of the skin prior to surgery
- First aid antiseptic to help reducce bacteria that potentially can cause skin infection
- For hospital and professional use
WARNINGS SECTION
Warnings For external use only.
Do not use:
- in the eyes.
- on individuals who are allergic or sensitive to iodine
- as a first aid antiseptic longer than 1 week unless directed by a doctor.
OTC - ASK DOCTOR SECTION
Ask a doctor before use if you have
- deep or puncture wounds, animal bites or serious burns.
OTC - STOP USE SECTION
Stop use and ask a doctor if
- irritation or redness develop
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
DOSAGE & ADMINISTRATION SECTION
Directions
For preparation of the skin prior to surgery
- apply to the operative site prior to surgery
As a first aid antiseptic
- clean the affected area
- apply a small amount of this product to the area 1-3 times daily
- may be covered with a sterile bandage
- if bandaged, let dry first
INACTIVE INGREDIENT SECTION
Inactive Ingredients
Disodium hydrogen phosphate, Glycerin, Hydroxyethyl cellulose, Purified water
OTHER SAFETY INFORMATION
Other Information
Store at room temperature.
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
DailyMed RxNorm Mappings#
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 726062af-1135-4707-a1d7-57256991bbf9 | Product name | 2 | 20250226 |
| 5f30b278-5791-4113-8781-878a9221ef8a | Product name | 2 | 20230125 |
| 2a70c781-a755-4d76-b20a-a958acfbdcdc | Product name | 2 | 20190619 |
| 304592ef-4a8a-4c22-8e8c-af73aa3d60e5 | Product name | 1 | 20180703 |
| ac0821a1-ce75-4ea7-880a-59eecaecdf22 | Product name | 1 | 20180703 |
| db5dc4f9-b907-46f6-8fb7-babcf04bbe5c | Product name | 1 | 20180619 |
| 41e9d6cf-3ed7-4c44-a57e-0685058d0896 | Product name | 1 | 20170824 |
| 5e652c92-68fd-426b-b0e7-5fc64e0b9f99 | Product name | 1 | 20170309 |
| ddc0c11a-bba8-408f-b3c7-c4828b4bcc8c | Product name | 1 | 20150421 |
| 19c71a3d-ed9c-166b-a7e5-38c250c35631 | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 53152-2004-1 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-3393-a910-e053-dadaa90a0b85 | 95ee8832-9d2b-3b96-e053-2995a90aae4a |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 53152-2004-1 | ALPHA ONE | 118 mL in 1 BOTTLE, PLASTIC | GEL | 118 | 1 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 53152-2004 | ALPHA ONE (POVIDONE-IODINE) GEL [AOSS MEDICAL SUPPLY, INC.] | 1 | Legacy NDC, 1 package rows | 20191029_95ee8832-9d2b-3b96-e053-2995a90aae4a.zip |
Products#
Every source-derived product name is available through these pages.
- ALPHA ONE
- POVIDONE-IODINE
- HYDROXYETHYL CELLULOSE (2000 CPS AT 1%)
- SODIUM PHOSPHATE, DIBASIC, ANHYDROUS
- IODINE
- WATER
- GLYCERIN
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 53152-2004 | 53152-2004-1 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| HYDROXYETHYL CELLULOSE (2000 CPS AT 1%) | S38J6RZN16 | IACT |
| SODIUM PHOSPHATE, DIBASIC, ANHYDROUS | 22ADO53M6F | IACT |
| POVIDONE-IODINE | 85H0HZU99M | ACTIM |
| WATER | 059QF0KO0R | IACT |
| GLYCERIN | PDC6A3C0OX | 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 |
|---|---|---|---|---|---|---|
| 95ee8832-9d2c-3b96-e053-2995a90aae4a | 95ee8832-9d2b-3b96-e053-2995a90aae4a | 2019-10-23 | Warnings | 95ee8832-9d2c-3b96-e053-2995a90aae4a 95ee8832-9d2b-3b96-e053-2995a90aae4a |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.