NANOMIX BODY CARE- dimethicone lotion

NANOMIX BODY CARE by

Drug Labeling and Warnings

NANOMIX BODY CARE by is a Otc medication manufactured, distributed, or labeled by NANOPOLY CO., LTD., COSMAX INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient: Dimethicone 1.2%

INACTIVE INGREDIENT

Inactive Ingredient: Water, Glycerin, Cetyl Ethylhexanoate, Urea, Caprylic/Capric Triglyceride, Pentylene Glycol , Dimethicone, Cetearyl Alcohol, Butyrospermum Parkii (Shea) Butter, Zea Mays (Corn) Starch, Propanediol, Stearic Acid, Glyceryl Stearate, PEG-100 Stearate, Arachidyl Alcohol, Behenyl Alcohol, Olea Europaea (Olive) Fruit Oil, Caprylyl Glycol Fragrance(Parfum), Sodium Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Arachidyl Glucoside, Isohexadecane, Arginine, Xanthan Gum, Carbomer, Polysorbate, Colloidal Silver, Serine

PURPOSE

Purpose: Skin Protectant

WARNINGS

Warnings:
1. In case of having following symptoms after using this, you’re advised to stop using it immediately. If you keep using it, the symptoms will get worse and need to consult a dermatologist.
1) In case of having problems such as red rash, swollenness, itching, stimulation during usage.
2) In case of having the same symptoms above on the part you put this product on by direct sunlight.
2. You are banned to use it on the part where you have a scar, eczema, or dermatitis.
3. In case of getting it into your eyes, you have to wash it immediately.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children:
Keep out of reach of babies and children.

INDICATIONS AND USAGE

Indication and usage:
Avoid to direct sunlight.
Do not keep in hot(higer 40C) or cold(below 0C).
Rotate the cap of pump counterclockwise and then rise the cap, press the pump cap to use the lotion.

DOSAGE AND ADMINISTRATION

Dosage and administration:
Apply after washing body.
Take a small amount of lotion about 2g onto the fingertips and gently massage over the entire body.
Especially use the lotion over dry or itchy part 2-3 times per day.

PACKAGE LABEL. PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

NANOMIX BODY CARE 
dimethicone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54170-110
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Dimethicone (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	Dimethicone	4.8 mg  in 400 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Glycerin (UNII: PDC6A3C0OX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54170-110-01	400 mL in 1 CARTON

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	06/01/2013

Labeler - NANOPOLY CO., LTD. (687162537)

Registrant - NANOPOLY CO., LTD. (687162537)

Establishment
Name	Address	ID/FEI	Business Operations
NANOPOLY CO., LTD.		687162537	repack(54170-110)

Establishment
Name	Address	ID/FEI	Business Operations
COSMAX INC.		689019313	manufacture(54170-110)