DIABETICS INTENSIVE MOISTURIZING- diabetics intensive moisturizing cream 
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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Diabetics intensive moisturizing

Active Ingredients

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, phenoxyethanol, hexylene glycol, tocopheryl acetate, allantoin, carbomer, disodium EDTA, aloe barbadensis leaf juice, sodium hydroxide

4oz.Intensive tube front

tbes

intensive packet

intensive packet

DIABETICS INTENSIVE MOISTURIZING 
diabetics intensive moisturizing cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:56151-681
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
WATER (UNII: 059QF0KO0R)  
ALLANTOIN (UNII: 344S277G0Z)  
GLYCERIN (UNII: PDC6A3C0OX)  
ALOE (UNII: V5VD430YW9)  
ETHYLHEXYL PALMITATE (UNII: 2865993309)  
BEHENYL ERUCATE (UNII: 681898L9A8)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
TRIBEHENIN (UNII: 8OC9U7TQZ0)  
OCTYLDODECYL BEHENATE (UNII: BZM9WE5P6F)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:56151-681-04113 g in 1 TUBE; Type 0: Not a Combination Product02/27/2015
2NDC:56151-681-022 g in 1 PACKET; Type 0: Not a Combination Product06/12/2015
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34702/27/2015
Labeler - Trividia Health, Inc. (151810868)
Establishment
NameAddressID/FEIBusiness Operations
Trividia Manufacturing Solutions, Inc018927392manufacture(56151-681) , label(56151-681) , pack(56151-681)

Revised: 2/2022
Document Id: d82542ec-5158-c4ad-e053-2995a90aa64a
Set id: baf79b5a-fb86-4a34-a4d0-09e9a0320281
Version: 17
Effective Time: 20220216
 
Trividia Health, Inc.