SUNMARK POVIDONE-IODINE TOPICAL- povidone-iodine solution 
Strategic Sourcing Services LLC

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Sunmark Povidone-Iodine 10% Topical Solution

sunmark Povidone-Iodine 10% Topical Solution


Active Ingredient

Povidone Iodine 10%  (*Equivalent to 1% titratable Iodine)

Purpose

Antiseptic

Uses

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

Warnings

For external use only.

Do not:

  • use in the eyes.
  • use longer than 1 week unless directed by a doctor.
  • use on individuals who are allergic or sensitive to iodine.
  • apply over large areas of the body.

Stop use and consult a doctor if

  • condition persists or gets worse.
  • irritation and redness develop and persist for more than 72 hours.

Ask a doctor in case of:

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

Keep out of reach of children.

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

Directions

Other Information

Store at room temperature, 20-25 0 C (68-77 0 F).

Inactive Ingredients:

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

COMPARE TO BETADINE ACTIVE INGREDIENT*   sunmark povidone-iodine 10% Topical Solution  FIRST AID ANTISEPTIC  16 FL OZ (PT) 473mL  *This product is not manufactured or distributed by Purdue Frederick, owner of the registered trademark Betadine

sunmark Povidone-Iodine 10% Topical Solution 8oz (49348-622-37) | sunmark Povidone-Iodine 10% Topical Solution 16oz (49348-622-38)

Povidone 8 ozPovidone 16 oz

SUNMARK POVIDONE-IODINE TOPICAL 
povidone-iodine solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49348-622
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4) IODINE1 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
GLYCERIN (UNII: PDC6A3C0OX)  
NONOXYNOL-9 (UNII: 48Q180SH9T)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49348-622-37237 mL in 1 BOTTLE; Type 0: Not a Combination Product12/15/2017
2NDC:49348-622-38473 mL in 1 BOTTLE; Type 0: Not a Combination Product12/15/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM00306/28/2012
Labeler - Strategic Sourcing Services LLC (116956644)
Registrant - Pharma Nobis, LLC (118564114)
Establishment
NameAddressID/FEIBusiness Operations
Pharma Nobis, LLC118564114manufacture(49348-622) , analysis(49348-622) , pack(49348-622) , label(49348-622)

Revised: 12/2023
Document Id: 0ce5be01-e0b9-7245-e063-6294a90acccf
Set id: acc349d6-2875-4814-aa6e-828fffec7f07
Version: 9
Effective Time: 20231219
 
Strategic Sourcing Services LLC