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NDC 56151-0682-04 TRUEplus diabetics foot care 5 g/100g Details

TRUEplus diabetics foot care 5 g/100g

TRUEplus diabetics foot care is a TOPICAL CREAM in the HUMAN OTC DRUG category. It is labeled and distributed by Trividia Health, Inc.. The primary component is DIMETHICONE.

Product Information

NDC	56151-0682
Product ID	56151-682_b5a9beb6-96b6-a63f-e053-2a95a90a1a20
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	TRUEplus diabetics foot care
Proprietary Name Suffix	n/a
Non-Proprietary Name	TRUEplus diabetics foot care
Product Type	HUMAN OTC DRUG
Dosage Form	CREAM
Route	TOPICAL
Active Ingredient Strength	5
Active Ingredient Units	g/100g
Substance Name	DIMETHICONE
Labeler Name	Trividia Health, Inc.
Pharmaceutical Class	Skin Barrier Activity [PE]
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part347
Listing Certified Through	n/a

Package

Package Images

NDC 56151-0682-04 (56151068204)

Pricing Information	N/A
NDC Package Code	56151-682-04
Billing NDC	56151068204
Package	113 g in 1 TUBE (56151-682-04)
Marketing Start Date	2015-02-27
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL ca481b31-55fc-47c5-ae9e-b7d8db3ce906 Details

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

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