Sunmark Povidone-iodine Topical Solution
FDA Label NDC 49348-622

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Strategic Sourcing Services Llc for the product Sunmark Povidone-iodine Topical (NDC 49348-622). 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 sunmark povidone-iodine 10% topical solution, active ingredient, purpose, uses, warnings, do not:, stop use and consult a doctor if, ask a doctor in case of:, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

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.

Directions

  • Clean the affected area
  • Apply a small amount on the area 1 to 3 times daily.
  • May be covered with a sterile bandage.
  • If bandaged, let dry first.

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.

Package Label.Principal Display Panel

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

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* Please review the disclaimer below.