TRUEplus Diabetics Intensive Moisturizing: Package Insert and Label Information

TRUEPLUS DIABETICS INTENSIVE MOISTURIZING- dimethicone cream
Nipro Diagnostics, 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 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

intensive packet

Front panel
(click image for full-size original)

4oz.Intensive tube front

4oz intensive front panel
(click image for full-size original)

TRUEPLUS DIABETICS INTENSIVE MOISTURIZING
trueplus diabetics intensive moisturizing cream
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:56151-681
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
WATER
ALLANTOIN
GLYCERIN
ALOE
ETHYLHEXYL PALMITATE
BEHENYL ERUCATE
STEARIC ACID
CETOSTEARYL ALCOHOL
SODIUM HYDROXIDE
ALPHA-TOCOPHEROL ACETATE
CARBOMER INTERPOLYMER TYPE A (55000 CPS)
CAPRYLYL GLYCOL
PHENOXYETHANOL
HEXYLENE GLYCOL
EDETATE DISODIUM
TRIBEHENIN
OCTYLDODECYL BEHENATE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:56151-681-04 113 g in 1 TUBE None
2 NDC:56151-681-02 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 — Nipro Diagnostics, Inc. (151810868)
Establishment
Name Address ID/FEI Operations
Nipro Consumer Healthcare, Inc. 018927392 manufacture (56151-681), label (56151-681), pack (56151-681)

Revised: 06/2015 Nipro Diagnostics, Inc.

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