Active Ingredient
Aluminum acetate (0.2%)
Dermeleve Cream
FDA Label NDC 81507-003
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Advanced Derm Solutions Llc for the product Dermeleve (NDC 81507-003). 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 ingredient, purpose, uses, warnings, directions, inactive ingredients, product label, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Astringent
Uses
• Insects Bites
• Minor Burn
• Athlete's foot
• Poison lvy
• Poison oak
• Poison sumac
• Rashes cause by soaps, detergents, cosmetic or jewelry
Warnings
■
For external use only.
■
Avoid contact with eyes.
■
Do not apply to open wounds.
■
STOP USE and ask a physician if condition worsens
or symptoms persist for more than seven days.
■ Keep out of reach of children.
Directions
Adults and children two years of age and older,
apply to affected area as needed or as directed by a physician. Consult a physician for children under the age of two.
Inactive Ingredients
Caprylyc/Capric Triglyceride, Caprylyl Glycol, Ceramide NG, Cetearyl Alcohol, Dimethicone 100,
Disodium Edta, Emulsifying Wax NF, Glycerin, Glyceryl Stearate SE, Sodium Hyaluronate, Isopropyl Myristate Magnesium Aluminum Silicate Type IA, Phenoxyethanol, Polyacrylate Crosspolymer-6, Shea Butter, Strontium Nitrate, Tetrahexyldecyl Ascorbate, Tocopherol, Water O-18, Xanthan Gum
Product Label
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