Otc - Active Ingredient
Undecylenic Acid (10%), Zinc Oxide (15%)
Intertrigo Relief Cream
FDA Label NDC 85593-030
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Guangzhou Chuanma International Trading Co.,ltd. for the product Intertrigo Relief (NDC 85593-030). 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 otc - active ingredient, otc - purpose, otc - keep out of reach of children, dosage & administration, warnings, indications & usage, inactive ingredient, 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
Otc - Purpose
Helps soothe skin fold rash (intertrigo) and irritation caused by moisture and friction in areas such as under the breasts, abdominal folds, inner thighs, andgroin.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children
Dosage & Administration
Use 2-3 times daily
Warnings
Warnings:For external use only. Avoid contact with eyes. Discontinue use ifirritation occurs. Keep out of reach of children.
Indications & Usage
A brief cooling or tingling sensation may be felt when first applied.. This is normal and typically fades within a few minutes. The cooling effect is part of how the formula works on irritated skin
Inactive Ingredient
Witch Hazel Extract, Tea Tree Oil,Glycerin, Purified Water.
Package Label.Principal Display Panel
Labeling (85593 030 01)
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