Otc - Active Ingredient
Active ingredient Purpose
Dimethicone 2.7% Skin Protectant
Ultimate Skin Protectant Derma Shield
FDA Label NDC 70233-010
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Fleet Laboratories Ltd for the product Ultimate Skin Protectant Derma Shield (NDC 70233-010). 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
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
Otc - Keep Out Of Reach Of Children
Keep out of reach of children
Indications & Usage
Stop use and ask a doctor if:
- condition worsens
- symptoms last more than 7 days or clear up again within a few days
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°F
Dosage & Administration
Directions
- Apply as needed
- Children under 6 months: ask a doctor
- Wash and dry skin area
- Shake can vigourously
- Invert can and apply "golf Ball" size amount in palm
- Rub thoroughly onto the skin
- Allow to dry
Inactive Ingredient
Inactive ingredients Water, Propane, Butane, Palmitic acid, Palm Kernal acid, Isopropyl Myristate, 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 Diazolidinyl Urea, Methylparaben, Propylparaben, Sodium Benzoate, Potassium Sorbate,Citric Acid.
Package Label.Principal Display Panel
Benchmark's
DermaShield
The Ultimate Skin Protectant
Net Weight 17 oz(1lb 1 oz) (482g)
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