Ichthammol 20% Ointment
FDA Label NDC 69396-004
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Trifecta Pharmaceuticals Usa Llc for the product Ichthammol 20% (NDC 69396-004). 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 - keep out of reach of children, suggested use, warnings, directions, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient
Ichthammol 20%
Purpose
Drawing Salve
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
Suggested Use
• Treating insect bites and stings from mosquitoes, spider, and bees • Removing splinters and silvers • Treating plant irritations, such as nettles or poison ivy • Treating minor skin infections such as an ingrown toenail • Soothing skin relief • Apply to minor skin irritations
Warnings
• For external use only • Do not use in eyes • Ask a doctor before use if you have deep puncture wounds or serious burns • Stop use and ask doctor if redness, irritation, swelling or pain persists
If swallowed, get medical help or contact a Poison Control Center immediately.
Before using any medication, read all label directions.
Keep this carton, it contains important information.
Directions
Cleanse affected area. Apply on gauze bandage once or twice a day. Repeat as necessary. Do not rub or massage affected area.
Inactive Ingredients
Lanolin, Petrolatum
Other
Distributed by:
Trifecta Pharmaceuticals USA TM
101 NE Third Avenue, Suite 1500
Ft. Lauderdale, FL 33301 USA
1-888-296-9067
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