Dimethicone 1 Skin Protectant Lotion
FDA Label NDC 52000-417
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Universal Distribution Center Llc for the product Dimethicone 1 Skin Protectant (NDC 52000-417). 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 drug facts, active ingredient, purpose, uses, warnings, otc - keep out of reach of children, directions, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient
Dimethicone 1%
Purpose
Skin protectant
Uses
• Helps prevent and temporarily protects chafed, chapped or cracked skin.
• Helps prevent and protect from the drying effects of wind and cold weather.
Warnings
For external use only.
When using this product
• Do not get into eyes.
Stop use and ask a doctor if
• Conditions worsens.
• Symptoms last more than 7 days or clear up and occur again within a few days.
Do not use on • Deep or puncture wounds • Animal bites • Serious burns.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center Immediately.
Directions
Apply as needed.
Inactive Ingredients
water, cetearyl alcohol, mineral oil, glycerin, petrolatum, ceteareth-20, propylene glycol, cetrimonium chloride, carbomer, benzyl alcohol, methylchloroisothiazolinone, methylisothiazolinone, sodium hydoxide, avena sativa (oat) kernel flour, tocopheryl acetate, FD&C yellow no.6, FD&C yellow no.5, FD&C blue no.1
Packaging
Skinprotectant-417 (52000417 2)
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