Otc - Active Ingredient
Active Ingredients:
Povidone-iodine USP 10% w/v
Alpha One
FDA Label NDC 53152-2004
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Aoss Medical Supply, Inc. for the product Alpha One (NDC 53152-2004). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, indications & usage, warnings, otc - ask doctor, otc - stop use, otc - keep out of reach of children, dosage & administration, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Purpose
Antiseptic
Indications & Usage
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
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
Ask a doctor before use if you have
- deep or puncture wounds, animal bites or serious burns.
Otc - Stop Use
Stop use and ask a doctor if
- irritation or redness develop
Otc - 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.
Dosage & Administration
Directions
For preparation of the skin prior to surgery
- apply to the operative site prior to surgery
- 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
As a first aid antiseptic
Inactive Ingredient
Inactive Ingredients
Disodium hydrogen phosphate, Glycerin, Hydroxyethyl cellulose, Purified water
Other Safety Information
Other Information
Store at room temperature.
Package Label.Principal Display Panel
Image Of Bottle Label (Iogel)
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