FASCY MOISTURE BOMB HAND STRAWBERRY 40ML- dimethicone cream

Fascy Moisture Bomb Hand Strawberry 40mL by

Drug Labeling and Warnings

Fascy Moisture Bomb Hand Strawberry 40mL by is a Otc medication manufactured, distributed, or labeled by FASCY Co,.LTD., WELCOS CO.,LTD.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient: Dimethicone 1.0%

INACTIVE INGREDIENT

Inactive Ingredients: Water, Glycerin, Cetearyl Alcohol, Mineral Oil, Dipropylene Glycol, Cyclopentasiloxane, Glyceryl Stearate, PEG-100 Stearate, Polysorbate 60, Sorbitan Stearate, Sodium Polyacrylate, Ethylhexyl Stearate, Xanthan Gum, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Adenosine, Butylene Glycol, Potassium Hydroxide, Trideceth-6, Butyrospermum Parkii (Shea) Butter, Panthenol, Fragaria Chiloensis (Strawberry) Fruit Extract, Allantoin, Ethylhexylglycerin, Aloe Barbadensis Leaf Extract, Disodium EDTA, Methylparaben, Propylparaben, Phenoxyethanol, CI 17200, CI 19140, CI 14700, Fragrance

PURPOSE

Purpose: Skin Protectant

WARNINGS

Warnings: For external use only. When using this product do not get into eyes, Stop use and ask a doctor if rash occurs. Do not use on - deep puncture wounds - animal bites - serious burns. Keep out of reach of children. Do not keep it in direct sunlight, high or low temperature.

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN

How to use

How to use: Apply desired amount and massage into the hands.

How to use

How to use: Apply desired amount and massage into the hands.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

FASCY MOISTURE BOMB HAND STRAWBERRY 40ML 
dimethicone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70991-080
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Dimethicone (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	Dimethicone	0.4 g  in 40 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: 70991-080-02	1 in 1 CARTON	02/01/2017
1	NDC: 70991-080-01	40 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	02/01/2017

Labeler - FASCY Co,.LTD. (689204222)

Registrant - FASCY Co,.LTD. (689204222)

Establishment
Name	Address	ID/FEI	Business Operations
FASCY Co,.LTD.		689204222	relabel(70991-080)

Establishment
Name	Address	ID/FEI	Business Operations
WELCOS CO.,LTD.		689131584	manufacture(70991-080)