Otc - Active Ingredient
Active ingredient
Dimethicone, 2.7%
Benchmarks Derma Shield
FDA Label NDC 70557-002
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Delta Kits Inc for the product Benchmarks Derma Shield (NDC 70557-002). 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, indications & usage, warnings, dosage & administration, 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
Purpose
Skin protectant
Otc - Keep Out Of Reach Of Children
Do not use on:
- deep or puncture wounds
- animal bites
- serious burns
- Keep out of reach of children
Indications & Usage
Uses
- helps prevent and temporarily protects and helps relieve chafed, chapped, or cracked skin
- helps prevent and protect from the drying effects or wind and cold weather
Warnings
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 120 oF
Dosage & Administration
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" size amount in palm
- Rub thoroughly onto the skin
- Alllow to dry
Inactive Ingredient
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
* Please review the disclaimer below.
