Active Ingredients
Iodine 2%, Sodium Iodide 2.4%, Alcohol 47%
Sunmark Iodine Tincture
FDA Label NDC 49348-133
8 label sections · Submitted to the FDA by Strategic Sourcing Services Llc · 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 Iodine (NDC 49348-133). 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 active ingredients, purpose, uses, warnings:, directions:, inactive ingredient:, otc - keep out of reach of children, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Antiseptic
Uses
To help prevent infection in minor cuts, scrapes and burns.
Warnings:
For external use only.
Directions:
Clean the affected area. Apply a small amount to the affected area 1 to 3 times daily. May be covered with a sterile bandage. If bandaged, let dry first.
Inactive Ingredient:
Purified Water.
Otc - Keep Out Of Reach Of Children
In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.
Package Label.Principal Display Panel
Iodine (Iodine)
* Please review the disclaimer below.
