SELECT BRAND POVIDONE IODINE- povidone iodine 10% liquid 
Select Brand Distributors

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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Select Brand Povidone Iodine

Drug Facts

Active Ingredient

Povidone-Iodine 10%

(Equivalent to 1% titrable iodine)

Purpose

Antiseptic

Use

First aid antiseptic to prevent infection in minor cuts and burns.

Warnings

For External Use Only

Ask a doctor before use if you have

Stop use and consult a doctor if

When using this product do not

Keep out of reach of children.

In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.

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 on the area 1 to 3 times daily. May be covered with sterile bandage. If badaged, let it dry first.

Other information

store at room temperature, 20-25C (68-77F)

Inactive Ingredients

Citric Acid, Disodium Phosphate, Glycerin, nonoxynol-9. Sodium Hydroxide and Purified Water.

Principal Display Panel

Label 8 fl oz

Label 8 fl oz

SELECT BRAND POVIDONE IODINE 
povidone iodine 10% liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:15127-052
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4) IODINE100 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
GLYCERIN (UNII: PDC6A3C0OX)  
NONOXYNOL-9 (UNII: 48Q180SH9T)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:15127-052-55237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/12/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A01/01/2008
Labeler - Select Brand Distributors (012578514)
Registrant - Humco Holding Group, Inc. (825672884)
Establishment
NameAddressID/FEIBusiness Operations
Humco Holding Group, Inc.825672884manufacture(15127-052) , analysis(15127-052) , pack(15127-052) , label(15127-052)

Revised: 12/2017
Document Id: 602c8d13-0fd4-8143-e053-2a91aa0acb3a
Set id: e0cb8856-6cee-43cc-af00-8664d65345a3
Version: 2
Effective Time: 20171212
 
Select Brand Distributors