TRUEPLUS DIABETICS FOOT CARE- trueplus diabetics foot care 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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TRUEplus diabetics foot care

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 swalowed, get medical help or contact a Poison Control Center immediately.

Directions

apply as neded 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, bisabolol (and) zingiber officinate (ginger) root extract, cholesterol, disodium EDTA, aloe barbadensis leaf juice, sodium hydroxide

SPL Unclassified Section

Manufactured for:

Trividia Health, Inc.,

Fort Lauderdale, FL 33309

1-800-803-6025

Made in USA

www.trividiahealth.com

4oz. diabetics foot care cream tube

4oz tube foot

Foot Cream Packet

2g packet

TRUEPLUS DIABETICS FOOT CARE
trueplus diabetics foot care cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:56151-682
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	5 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
EDETATE DISODIUM (UNII: 7FLD91C86K)
GINGER (UNII: C5529G5JPQ)
LEVOMENOL (UNII: 24WE03BX2T)
OCTYLDODECYL BEHENATE (UNII: BZM9WE5P6F)
ALLANTOIN (UNII: 344S277G0Z)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
ALOE (UNII: V5VD430YW9)
CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
TRIBEHENIN (UNII: 8OC9U7TQZ0)
BEHENYL ERUCATE (UNII: 681898L9A8)
STEARIC ACID (UNII: 4ELV7Z65AP)
CHOLESTEROL (UNII: 97C5T2UQ7J)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:56151-682-04	113 g in 1 TUBE; Type 0: Not a Combination Product	02/27/2015
2	NDC:56151-682-02	2 g in 1 PACKET; Type 0: Not a Combination Product	02/27/2015

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part347	02/27/2015	08/31/2023

Labeler - Trividia Health, Inc. (151810868)

Name	Address	ID/FEI	Business Operations
Establishment
Trividia Manufacturing Solutions, Inc		018927392	manufacture(56151-682) , label(56151-682) , pack(56151-682)

Revised: 12/2020

Document Id: b5a9beb6-96b6-a63f-e053-2a95a90a1a20

Set id: ca481b31-55fc-47c5-ae9e-b7d8db3ce906

Version: 17

Effective Time: 20201204

Trividia Health, Inc.