ESSENTIALS TRIAL KIT- essentials trial kit 
Trividia Health, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Essentials Trial Kit

Active Ingredient

Dimethicone 5%

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

ESSENTIALS TRIAL KIT 
essentials trial kit kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:56151-683
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:56151-683-041 in 1 KIT; Type 0: Not a Combination Product03/18/201601/30/2021
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 PACKET 2 g
Part 1 of 1
INTENSIVE MOISTURIZING 
intensive moisturizing cream
Product Information
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
ALOE (UNII: V5VD430YW9)  
ETHYLHEXYL PALMITATE (UNII: 2865993309)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
GLYCERIN (UNII: PDC6A3C0OX)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
ALLANTOIN (UNII: 344S277G0Z)  
TRIBEHENIN (UNII: 8OC9U7TQZ0)  
CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)  
HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
WATER (UNII: 059QF0KO0R)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
OCTYLDODECYL BEHENATE (UNII: BZM9WE5P6F)  
BEHENYL ERUCATE (UNII: 681898L9A8)  
Product Characteristics
Color    Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
12 g in 1 PACKET; Type 0: Not a Combination Product
Image of Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34703/18/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34703/18/2016
Labeler - Trividia Health, Inc. (151810868)

Revised: 12/2019
Document Id: 9a150372-ae1e-f080-e053-2995a90a813f
Set id: 2cef2570-84e3-0b15-e054-00144ff8d46c
Version: 6
Effective Time: 20191219
 
Trividia Health, Inc.