TRUEplus Diabetics Foot Care: Package Insert and Label Information

TRUEPLUS DIABETICS FOOT CARE- dimethicone 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.

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
(click image for full-size original)

Foot Cream Packet

2g packet
(click image for full-size original)

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 DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DIMETHICONE (DIMETHICONE) DIMETHICONE 5 g in 100 g
Inactive Ingredients
Ingredient Name Strength
CAPRYLYL GLYCOL
CETOSTEARYL ALCOHOL
PHENOXYETHANOL
HEXYLENE GLYCOL
EDETATE DISODIUM
GINGER
LEVOMENOL
OCTYLDODECYL BEHENATE
ALLANTOIN
WATER
GLYCERIN
ALOE
CARBOMER INTERPOLYMER TYPE A (55000 CPS)
ETHYLHEXYL PALMITATE
TRIBEHENIN
BEHENYL ERUCATE
STEARIC ACID
CHOLESTEROL
SODIUM HYDROXIDE
ALPHA-TOCOPHEROL ACETATE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:56151-682-04 113 g in 1 TUBE None
2 NDC:56151-682-02 2 g in 1 PACKET None
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 Operations
Trividia Manufacturing Solutions, Inc 018927392 manufacture (56151-682), label (56151-682), pack (56151-682)

Revised: 12/2017 Trividia Health, Inc.

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