DIABETICS INTENSIVE MOISTURIZING cream

Diabetics intensive moisturizing by

Drug Labeling and Warnings

Diabetics intensive moisturizing 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 Ingredients

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 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, ethylhexyl palmitate, glyceryl tribehenate, glycerin, stearic acid, cetearyl alcohol, behenyl erucate, octyldodecyl behenate, caprylyl glycol, phenoxyethanol, hexylene glycol, tocopheryl acetate, allantoin, carbomer, disodium EDTA, aloe barbadensis leaf juice, sodium hydroxide

4oz.Intensive tube front

intensive packet

INGREDIENTS AND APPEARANCE

DIABETICS INTENSIVE MOISTURIZING 
diabetics intensive moisturizing cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 56151-681
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
WATER (UNII: 059QF0KO0R)
ALLANTOIN (UNII: 344S277G0Z)
GLYCERIN (UNII: PDC6A3C0OX)
ALOE (UNII: V5VD430YW9)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
BEHENYL ERUCATE (UNII: 681898L9A8)
STEARIC ACID (UNII: 4ELV7Z65AP)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
EDETATE DISODIUM (UNII: 7FLD91C86K)
TRIBEHENIN (UNII: 8OC9U7TQZ0)
OCTYLDODECYL BEHENATE (UNII: BZM9WE5P6F)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 56151-681-04	113 g in 1 TUBE; Type 0: Not a Combination Product	02/27/2015
2	NDC: 56151-681-02	2 g in 1 PACKET; Type 0: Not a Combination Product	06/12/2015

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(56151-681) , label(56151-681) , pack(56151-681)