Benchmarks Derma Shield
FDA Label NDC 80905-001

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Star Colour Laboratories for the product Benchmarks Derma Shield (NDC 80905-001). 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(s), uses, purpose, warnings, do not use on:, directions, inactive ingredients, 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

Active Ingredient(S)

Dimethicone, 2.7%

Uses

  • Helps prevent and temporarily protects and helps relieve chafed, chapped or cracked skin
  • Helps prevent and protect from the drying effects of wind and cold weather

Purpose

Skin protectant

Warnings

For external use only

Flammable:

  • Do not use near flame or spark or while smoking
  • Contents under pressure
  • Do not puncture or incinerate
  • Do not store at temperature above 120oF

Do Not Use On:

  • deep or puncture wounds
  • animal bites
  • serious burns
  • keep out of reach of children

Directions

  • Apply as needed
  • Children under 6 months: ask a doctor
  • Wash and dry skin area
  • Shake can vigorously
  • Invert can and apply "golf ball" sized amount in palm
  • Rub thoroughly onto the skin
  • Allow to dry

Inactive Ingredients

Water, Propane, Butane, Palmitic acid, Palm Kernal acid, Isopropyl Myrisate, Glycerin, VP/VA Copolymer, Isobutane, Triethanolamine, Cetyl Alcohol, Cetearyl Alcohol, Ceteareth-20, Hydroxyethylcellulose, Perfluorianted Polyether, Aloe Barbadensis Leaf Juice, Tocopheryl Acetate, Lanolin, Tetrasodium EDTA, Propylene Glycol Diazolindinyl Urea, Methylparaben, Propylparaben, Sodium Benzoate, Potassium Sorbate, Citric Acid

Package Label.Principal Display Panel

Derma Shield 2oz Aerosol USA

Derma Shield 6oz Aerosol USA

Derma Shield 17oz Aerosol USA

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