TRUEPLUS DIABETICS DAILY HYDRATING- trueplus diabetics daily hydrating lotion lotion
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 daily hydrating lotion

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

4ozdailylotion

Daily packet 2g

2gdailylotionlabel

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

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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part347	01/29/2016	10/30/2020

Labeler - Trividia Health, Inc. (151810868)

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

Revised: 10/2020

Document Id: b2e8f854-e158-2e40-e053-2a95a90a483c

Set id: 2618b878-9698-0011-e054-00144ff88e88

Version: 4

Effective Time: 20201030

Trividia Health, Inc.