Zinc-oxyde Plus
FDA Label NDC 75983-006
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by First Aid Research Corp. for the product Zinc-oxyde Plus (NDC 75983-006). 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 ingredients, purpose, uses, warnings, directions, inactive ingredients, questions?, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredients
Menthol 0.44%
Zinc Oxide 20.6%
Purpose
External analgesic / Anti-itch
Skin protectant / Anorectal astringent
Uses
A moisture barrier that prevents and helps heal skin irritation from: • urine • diarrhea • perspiration • fistula damage • feeding tube site leakage • wound drainage (peri-wound skin) • minor burns • cuts • scrapes • itching
Warnings
For external use only
• not for deep or puncture wounds
• avoid contact with eyes
Directions
- cleanse skin gently with mild skin cleanser
- pat dry or allow to air dry
- apply a thin layer of ointment to reddened or irritated skin 2-4 times daily, or after each incontinent episode or diaper change to promote comfort and long lasting protection.
Inactive Ingredients
butylated hydroxytoluene, calamine, cetyl esters, glycerin, glycerol monostearate, lanolin, PEG-40 hydrogenated castor oil, phenol, sodium bicarbonate, thymol, white petrolatum
Questions?
call 516-783-0274
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Label (Zinc Oxyde)
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