TRUEPLUS DIABETICS DAILY HYDRATING- trueplus diabetics daily hydrating lotion lotion

TRUEplus diabetics daily hydrating by

Drug Labeling and Warnings

TRUEplus diabetics daily hydrating 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 2%

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, petrolatum, glyceryl stearate (and) PEG-100 stearate, cetearyl alcohol (and) ceteareth-20, glycerin, caprylyl glycol (and) phenoxyethanol (and) hexylene glycol, stearic acid, allantoin, xanthan gum, disodium EDTA, tocopherol, 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.Dailytube

Daily packet 2g

INGREDIENTS AND APPEARANCE

TRUEPLUS DIABETICS DAILY HYDRATING 
trueplus diabetics daily hydrating lotion lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 56151-680
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	2 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)
WATER (UNII: 059QF0KO0R)
STEARIC ACID (UNII: 4ELV7Z65AP)
TOCOPHEROL (UNII: R0ZB2556P8)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
EDETATE DISODIUM (UNII: 7FLD91C86K)
GLYCERYL 1-STEARATE (UNII: 258491E1RZ)
PEG-100 STEARATE (UNII: YD01N1999R)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
ALLANTOIN (UNII: 344S277G0Z)
GLYCERIN (UNII: PDC6A3C0OX)
XANTHAN GUM (UNII: TTV12P4NEE)
PETROLATUM (UNII: 4T6H12BN9U)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 56151-680-04	113 g in 1 TUBE; Type 0: Not a Combination Product	01/29/2016
2	NDC: 56151-680-02	2 g in 1 PACKET; Type 0: Not a Combination Product	01/29/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	01/29/2016

Labeler - Trividia Health, Inc. (151810868)

Establishment
Name	Address	ID/FEI	Business Operations
Trividia Manufacturing Solutions, Inc		018927392	manufacture(56151-680) , pack(56151-680) , label(56151-680)