Active Ingredients
Petrolatum 85%
Dimethicone 1.5%
Skin-lube Ointment
FDA Label NDC 82345-860
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by The Hygenic Company, Llc. for the product Skin-lube (NDC 82345-860). 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 ingredients, purpose, uses, warnings, do not use on, when using this product, stop use and ask a doctor if, keep out of reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Skin Protectant
Uses
Temporarily protects minor • cuts • scrapes • burns – Helps prevent, temporarily protects, and helps relieve chafed, chapped or cracked skin. Helps prevent and protect from the drying effects of wind and cold weather.
Warnings
For external use only.
Do Not Use On
• deep or puncture wounds • animal bites • serious burns
When Using This Product
do not get into eyes.
Stop Use And Ask A Doctor If
• condition worsens • symptoms last more than 7 days or clear up and occur again within a few days.
Keep Out Of Reach Of Children.
If swallowed, get medical help or contact a Poison Control Center right away.
Directions
Apply as needed.
Other Information
– Store in a cool dry place with lid closed tightly.
Inactive Ingredients
– Diazolidinyl Urea, Methylparaben, Propylene Glycol, Propylparaben, Zinc Stearate
Questions?
(800) 345-2231
Package Labeling:82345-860-25
Label2 (Label2)
Package Labeling:82345-860-05
Label3 (Label3)
Package Labeling:82345-860-01
Label4 (Label4)
Package Labeling:82345-860-02
Label5 (Label5)
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