ALPHA ONE- povidone-iodine gel

ALPHA ONE by

Drug Labeling and Warnings

ALPHA ONE by is a Otc medication manufactured, distributed, or labeled by AOSS Medical Supply, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients:
Povidone-iodine USP 10% w/v

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.

ASK DOCTOR

Ask a doctor before use if you have

• deep or puncture wounds, animal bites or serious burns.

STOP USE

Stop use and ask a doctor if

• irritation or redness develop

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

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

Inactive Ingredients

Disodium hydrogen phosphate, Glycerin, Hydroxyethyl cellulose, Purified water

OTHER SAFETY INFORMATION

Other Information

Store at room temperature.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ALPHA ONE 
povidone-iodine gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53152-2004
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4)	IODINE	10 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
HYDROXYETHYL CELLULOSE (2000 CPS AT 1%) (UNII: S38J6RZN16)
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53152-2004-1	118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	10/24/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	10/24/2019

Labeler - AOSS Medical Supply, Inc. (787524651)