Drug Facts
Drug facts
El Valle Decolorized Iodine Tincture
FDA Label NDC 55758-374
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Pharmadel Llc for the product El Valle Decolorized Iodine (NDC 55758-374). 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 drug facts, active ingredient & purpose, otc - purpose, uses, warnings, do not use, ask a doctor before use if you have, stop use and consult a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient & Purpose
Gentian Violet 1%
Otc - Purpose
| Active ingredient | Purpose |
| Alcohol 48% ............................. | First aid antiseptic |
Uses
First aid to help prevent infection in
- minor cuts
- scrapes
- burns
Warnings
FOR EXTERNAL USE ONLY.
Do Not Use
- longer than 1 week, unless directed by a doctor
- in the eyes
- over large areas of the body
Ask A Doctor Before Use If You Have
- a deep or puncture wounds
- serious burns
- animal bites
Stop Use And Consult A Doctor If
- conditions persist or gets worse
Keep Out Of Reach Of Children.
If swallowed, get medical help, or contact a Poison Control Center immediately.
Directions
- clean the affected area
- apply a small amount directly to the affected area 1 to 3 times a day
- may cover area with sterile bandage
Other Information
- do not use if clear seal over cap is missing or broken
Inactive Ingredients
ammonia, iodine, sodium iodide, water
* Please review the disclaimer below.
