Active Ingredient
Dimethicone 5%
Essentials Trial Kit
FDA Label NDC 56151-683
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Trividia Health, Inc. for the product Essentials Trial Kit (NDC 56151-683). 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, purpose, uses, warnings, when using this product, stop use and ask a doctor if, do not use on, 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
Helps relieve, prevent and temporarily protect chafed, chapped or cracked skin. helps protect from the drying effects of wind and cold weather
Warnings
For external use only
When Using This Product
avoid contact with eyes
Stop Use And Ask A Doctor If
condition worsens, symptoms persist for 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
Keep Out Of Reach Of Children
If swallowed, get medical help or contact a Poison Control Center immediately
Directions
apply as needed to dry, rough, or problem skin areas, reapply as often as needed
Inactive Ingredients
water, ethylhexyl palmitate, glyceryl tribehenate, glycerin, stearic acid, cetearyl alcohol, behenyl erucate, octyldodecyl behenate, caprylyl glycol (and) phenoxyethanol (and) hexylene glycol, tocopheryl acetate, allantoin, carbomer, disodium EDTA, aloe barbadensis leaf juice, sodium hydroxide
Kit Packet
Kit Packet (Kitbandrtwork)
* Please review the disclaimer below.
