Dermeleve
FDA Label NDC 81507-005

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 81507-005). 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

→ Active Ingredient

→ Purpose

→ Uses

→ Warnings

→ Directions

→ Inactive Ingredients

→ Product Label

Active Ingredient

Pramoxine Hydrochloride (1%)

Purpose

External analgesic

Uses

For temporary relief of pain and itching associated with skin irritations, minor burns, sunburn, and rashes due to poison ivy, poison oak, or poison sumac

Warnings

For external use only.
Avoidcontact with eyes.
Do not apply to open wounds.
STOP USE and ask a doctor 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 doctor.

Consult a doctor for children under the age of two.

Inactive Ingredients

Ascorbyl Tetraispalmitate, Butyrospermum Parkii (shea) Butter, Caprylic/Capric Triglyceride, Caprylyl Glycol, Ceramide NG, Cetearyl Alcohol
Dimethicone, Disodium EDTA, Glycerin, Glyceryl Stearate, Isopropyl Myristate, Magnesium Aluminum Silicate, Phenoxyethanol, Polyacrylate Crosspolymer-6, Polysorbate 60, Propylene Glycol, Sodium Hyaluronate, Strontium Nitrate, Tocopherol Acetate (Vitamin E), Water, Xanthan Gum