ALPHA ONE- povidone-iodine gel 
AOSS Medical Supply, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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

Purpose

Antiseptic

Uses

Warnings For external use only.

Do not use:

Ask a doctor before use if you have

Stop use and ask a doctor if

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

For preparation of the skin prior to surgery

As a first aid antiseptic

Inactive Ingredients

Disodium hydrogen phosphate, Glycerin, Hydroxyethyl cellulose, Purified water

Other Information

Store at room temperature.

image of bottle label

ALPHA ONE 
povidone-iodine gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53152-2004
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4) IODINE10 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
HYDROXYETHYL CELLULOSE (2000 CPS AT 1%) (UNII: S38J6RZN16)  
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)  
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:53152-2004-1118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/24/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A10/24/2019
Labeler - AOSS Medical Supply, Inc. (787524651)

Revised: 10/2019
Document Id: 95ee8832-9d2c-3b96-e053-2995a90aae4a
Set id: 95ee8832-9d2b-3b96-e053-2995a90aae4a
Version: 1
Effective Time: 20191023
 
AOSS Medical Supply, Inc.