TRUEPLUS DIABETICS FOOT CARE cream

TRUEplus diabetics foot care by

Drug Labeling and Warnings

TRUEplus diabetics foot care by is a Otc medication manufactured, distributed, or labeled by Trividia Health, Inc., Trividia Manufacturing Solutions, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

Foot Cream Packet

INGREDIENTS AND APPEARANCE

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

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

Inactive Ingredients
Ingredient Name	Strength
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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
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 Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	02/27/2015

Labeler - Trividia Health, Inc. (151810868)

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